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Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
February 21, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
February 21, 2012
Manufacturer
Amneal Pharmaceuticals
Registration number
ANDA200457
NDC root
65162-672
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to help relieve minor aches and pains that you might experience from common conditions like the cold, flu, sore throat, headache, or toothache. Additionally, it can help reduce fever, providing you with some comfort during these temporary ailments.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. This makes it a safer choice for those who may be pregnant or planning to become pregnant.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. To find the right dose for you or your child, refer to the dosing chart based on weight or age. It’s important to use only the measuring cup that comes with the medication to ensure accuracy.

If you need to take another dose, you can do so every 6 to 8 hours, but remember not to exceed four doses in a single day. For children under 2 years old, it’s best to consult a doctor before administering any medication. Here’s a quick guide for dosing based on weight and age:

  • For children weighing 24-35 lbs (ages 2-3 years), the dose is 1 teaspoon (5 mL).

  • For those weighing 36-47 lbs (ages 4-5 years), the dose is 1 ½ teaspoons (7.5 mL).

  • For children weighing 48-59 lbs (ages 6-8 years), the dose is 2 teaspoons (10 mL).

  • For those weighing 60-71 lbs (ages 9-10 years), the dose is 2 ½ teaspoons (12.5 mL).

  • Finally, for children weighing 72-95 lbs (age 11 years), the dose is 3 teaspoons (15 mL).

Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious risks.

Be cautious about the dosage; using more than directed or for a longer period than recommended may increase the risk of heart attack or stroke. Always follow the instructions carefully to ensure your child's safety.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. If you notice any of these symptoms, stop using the medication and seek medical help immediately.

Additionally, ibuprofen carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (like aspirin or naproxen). Be alert for signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. If your child experiences persistent stomach pain, fever, or pain that worsens or lasts more than three days, consult a doctor. Always seek medical advice if your child has a history of stomach issues, is dehydrated, or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication is a nonsteroidal anti-inflammatory drug (NSAID) and may lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs. Be cautious and do not use ibuprofen for more than two days for a sore throat, especially if accompanied by high fever, headache, nausea, or vomiting, and avoid giving it to children under 3 years old unless directed by a doctor.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help right away. You should also stop using ibuprofen and consult your doctor if your child shows signs of stomach bleeding (like feeling faint, vomiting blood, or having bloody or black stools), has persistent stomach pain, does not find relief within 24 hours, or if fever or pain worsens or lasts more than three days. Additionally, seek medical advice if redness or swelling occurs in the painful area or if any new symptoms appear.

Overdose

Taking too much ibuprofen can lead to serious health issues. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, stomach pain, drowsiness (extreme tiredness), and headache.

If you suspect an overdose, seek immediate medical help or contact a Poison Control Center right away. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should always consult your healthcare provider. They can help determine if it's appropriate for you and may suggest dosage adjustments based on your stage of pregnancy and individual health needs. Your health and the health of your baby are the top priority, so make sure to seek professional advice.

Lactation Use

If you are breastfeeding and considering using ibuprofen, it’s important to consult your doctor first. This is because ibuprofen can potentially pass into your breast milk, which may pose risks to your nursing infant. Therefore, exercising caution is advised when taking this medication while nursing. Always prioritize your health and your baby's safety by discussing any medications with your healthcare provider.

Pediatric Use

When considering this medication for your child, it's important to note that it should not be used in children under 3 years of age unless specifically directed by a doctor. For children aged 2 years and younger, always consult a doctor before administering. The dosage varies by weight and age: for children 24-35 lbs (2-3 years), the dose is 1 teaspoon (5 mL); for 36-47 lbs (4-5 years), it's 1 ½ teaspoons (7.5 mL); for 48-59 lbs (6-8 years), it's 2 teaspoons (10 mL); for 60-71 lbs (9-10 years), it's 2 ½ teaspoons (12.5 mL); and for 72-95 lbs (11 years), it's 3 teaspoons (15 mL).

Always consult a doctor if your child has a severe sore throat, especially if accompanied by high fever, headache, nausea, or vomiting. If your child has had an allergic reaction to pain relievers or has experienced serious side effects from them, stop use and consult a doctor. Be cautious if your child has a history of stomach problems, as there is a risk of stomach bleeding. Remember to follow the dosing instructions carefully: do not exceed the recommended amount, and if necessary, doses can be repeated every 6-8 hours, but no more than four times a day.

Geriatric Use

When considering ibuprofen for older adults, it's important to proceed with caution. Although specific studies on geriatric use are limited, elderly patients often have reduced kidney function, which can affect how the body processes the medication and may increase the risk of side effects. You might also notice that older adults can be more sensitive to these side effects.

Dosage adjustments may be needed based on individual health conditions and any other medications being taken. If you or a loved one has a history of gastrointestinal issues, heart problems, or kidney concerns, it's essential to monitor closely while using ibuprofen. Always consult with a healthcare provider to ensure safe and effective use.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to talk to your healthcare provider about any medications you or your child are taking, as certain combinations can lead to serious issues. For instance, if you or your child are allergic to aspirin, taking ibuprofen could trigger a severe allergic reaction. Additionally, if your child is on blood thinners or steroids, the risk of stomach bleeding increases when taking ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen.

Using ibuprofen for longer than recommended can also raise the risk of heart attack or stroke. If your child is taking a diuretic (a medication that helps remove excess fluid), this is another reason to consult with your healthcare provider to ensure safety and effectiveness. Always keep open communication about all medications and treatments to help prevent any harmful interactions.

Storage and Handling

To ensure the best use of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Before using, make sure to shake the bottle well. Always use the enclosed measuring cup for accurate dosing. It's important to check that the bottle wrap and the imprinted foil inner seal are intact; do not use the product if either is broken or missing.

After each use, replace the original bottle cap to keep it child-resistant. Remember to keep the carton, as it contains important information, including the expiration date, which you can find on the end panel. Following these guidelines will help ensure your safety and the effectiveness of the product.

Additional Information

You should take this medication orally, and if needed, you can repeat the dose every 6 to 8 hours, but do not exceed 4 doses in a day. It's important to shake the bottle well before each use and to measure your dose accurately using the enclosed measuring cup. If possible, use your weight to determine the right dose; otherwise, you can use your age. Always replace the original bottle cap to keep it child-resistant and store the medication in a cool, dry place between 20° to 25°C (68° to 77°F).

Before using, check that the bottle wrap and the imprinted foil inner seal are intact; do not use the product if either is broken or missing. Please note that this product does not include complete directions or warnings for adult use.

FAQ

What does this drug relieve?

This drug relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

How should I dose this medication?

You should find the right dose on the dosing chart based on your child's weight or age. Repeat the dose every 6-8 hours if needed, but do not exceed 4 doses in a day.

What should I do before using this medication?

Shake well before using and use only the enclosed measuring cup to ensure accurate dosing.

Are there any contraindications for this drug?

Do not use this medication if your child has ever had an allergic reaction to any other pain reliever or fever reducer, or if they are about to undergo heart surgery.

What are the allergy alerts associated with this drug?

This drug may cause a severe allergic reaction, especially in those allergic to aspirin. Symptoms can include hives, facial swelling, and difficulty breathing.

What should I do if my child experiences stomach bleeding?

Stop use and seek medical help immediately if your child experiences symptoms like faintness, vomiting blood, or has bloody or black stools.

Is this medication safe during pregnancy?

The safety of this medication during pregnancy has not been established, and it is contraindicated, especially in the third trimester.

Can nursing mothers use this medication?

Nursing mothers should consult a doctor before using this medication due to the potential for excretion in breast milk.

What should I do if my child has a severe sore throat?

Consult a doctor if your child has a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting.

How should I store this medication?

Store the medication between 20° to 25°C (68° to 77°F) and keep the carton for important information.

Packaging Info

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, flu, sore throat, headache, and toothache. Additionally, it is effective in reducing fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should instruct patients to shake the medication well before use. Dosing should be determined using the chart provided, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary measure. It is essential to utilize only the enclosed measuring cup for accurate dosing.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum frequency of four doses per day.

The dosing chart is as follows:

  • For patients under 2 years of age or weighing less than 24 lbs, consultation with a physician is advised prior to administration.

  • For patients weighing between 24-35 lbs (ages 2-3 years), the recommended dose is 1 teaspoon (5 mL).

  • For patients weighing between 36-47 lbs (ages 4-5 years), the recommended dose is 1 ½ teaspoons (7.5 mL).

  • For patients weighing between 48-59 lbs (ages 6-8 years), the recommended dose is 2 teaspoons (10 mL).

  • For patients weighing between 60-71 lbs (ages 9-10 years), the recommended dose is 2 ½ teaspoons (12.5 mL).

  • For patients weighing between 72-95 lbs (ages 11 years), the recommended dose is 3 teaspoons (15 mL).

Adherence to these guidelines will ensure safe and effective use of the medication.

Contraindications

Use is contraindicated in the following situations:

  • Patients with a history of allergic reactions to any pain reliever or fever reducer should not use this product, as it may trigger a similar response.

  • The product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (such as aspirin, ibuprofen, or naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of stomach bleeding.

Healthcare professionals should be vigilant regarding severe or persistent sore throat symptoms, particularly when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition. It is advised to consult a physician promptly in such cases. The use of this medication should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Discontinuation of ibuprofen is warranted, and a physician should be consulted if the child exhibits any of the following signs of potential stomach bleeding: feeling faint, vomiting blood, or passing bloody or black stools. Additionally, if stomach pain persists without improvement, if relief is not achieved within the first 24 hours of treatment, if fever or pain worsens or lasts beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use and seek immediate medical assistance.

The use of ibuprofen carries a risk of severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (such as aspirin or naproxen). The risk is further heightened if the medication is taken in excess or for prolonged periods beyond the recommended duration.

Patients should also be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, or having bloody or black stools. If any of these symptoms occur, or if stomach pain persists without improvement, it is crucial to stop use and consult a healthcare provider. Additionally, if fever or pain worsens or lasts more than three days, or if redness or swelling appears in the affected area, medical advice should be sought.

For children, specific precautions are advised. Parents should consult a doctor before administering ibuprofen if their child has experienced serious side effects from pain relievers or fever reducers, has a history of stomach issues such as heartburn, has not been adequately hydrated, or has lost significant fluids due to vomiting or diarrhea. Other conditions that warrant consultation include high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Furthermore, it is recommended to seek guidance from a healthcare professional if the child is under medical care for any serious condition or is taking other medications.

In clinical settings, it is advised that ibuprofen not be used for more than two days for sore throat symptoms, particularly in children under three years of age, unless directed by a physician.

Drug Interactions

Ibuprofen is associated with several significant drug interactions that warrant careful consideration.

Pharmacodynamic Interactions:

  • Allergic Reactions: Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. It is crucial to assess the patient's allergy history before prescribing ibuprofen.

  • Increased Risk of Gastrointestinal Bleeding: The concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of stomach bleeding. Additionally, co-administration with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, further increases this risk. Monitoring for gastrointestinal symptoms is advised in patients receiving these combinations.

  • Cardiovascular Risks: The use of ibuprofen beyond the recommended dosage or duration may heighten the risk of serious cardiovascular events, including heart attack and stroke. It is essential to adhere to prescribed dosages and treatment durations to mitigate these risks.

Pharmacokinetic Interactions:

  • Diuretics: In patients taking diuretics, ibuprofen may alter the effectiveness of the diuretic therapy. Close monitoring of renal function and blood pressure is recommended in these patients to ensure therapeutic efficacy and safety.

Healthcare providers should evaluate the potential for these interactions when prescribing ibuprofen and consider appropriate monitoring or dosage adjustments as necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For dosing, the following guidelines apply:

  • For children under 2 years, consultation with a doctor is required.

  • For those weighing 24-35 lbs (2-3 years), the recommended dose is 1 teaspoon (5 mL).

  • For children weighing 36-47 lbs (4-5 years), the dose is 1 ½ teaspoons (7.5 mL).

  • For those weighing 48-59 lbs (6-8 years), the dose is 2 teaspoons (10 mL).

  • For children weighing 60-71 lbs (9-10 years), the dose is 2 ½ teaspoons (12.5 mL).

  • For those weighing 72-95 lbs (11 years), the dose is 3 teaspoons (15 mL).

Healthcare professionals should advise parents to consult a doctor if the child experiences a severe or persistent sore throat, or if the sore throat is accompanied by high fever, headache, nausea, or vomiting. Additionally, parents should be instructed to stop use and seek medical advice if the child has a history of allergic reactions to pain relievers or fever reducers, or if they experience problems or serious side effects from these medications.

A warning regarding stomach bleeding is applicable for children with a history of stomach problems, such as heartburn, or if they have not been adequately hydrated. It is crucial to adhere to the recommended dosing guidelines, with doses not to exceed 4 times a day and to be repeated every 6-8 hours as needed.

Geriatric Use

Caution is advised when administering ibuprofen to elderly patients, as geriatric use has not been specifically studied. It is important to consider that elderly patients may have reduced kidney function, which can affect drug clearance and increase the risk of adverse effects. Additionally, these patients may exhibit increased sensitivity to side effects.

Dosage adjustments may be necessary based on individual health status and concurrent medications. Elderly patients with a history of gastrointestinal issues, cardiovascular disease, or renal impairment should be monitored closely while using this medication to ensure safety and efficacy.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss the potential risks and benefits. Additionally, dosage adjustments may be necessary based on the stage of pregnancy and individual health considerations.

Lactation

Nursing mothers are advised to consult a doctor prior to using ibuprofen. There is a potential for excretion of ibuprofen in breast milk, and caution is recommended when administering this medication to lactating mothers due to the potential risk to the breastfed infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of ibuprofen may lead to significant adverse effects. Healthcare professionals should be aware of the potential symptoms associated with an overdose, which can include nausea, vomiting, stomach pain, drowsiness, and headache.

In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance and management. Prompt intervention is crucial to mitigate the risks associated with ibuprofen overdosage and to ensure appropriate care is administered.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, as well as in those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, there is an observed increase in the risk of heart attack or stroke associated with the use of the product beyond the recommended duration or dosage.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed that this medication should not be used if the child has a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it is important to emphasize that the medication should not be administered right before or after heart surgery.

Healthcare providers should counsel patients to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. They should also be advised to stop use and seek medical advice if the child experiences stomach pain that does not improve, does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists for more than three days. Furthermore, patients should be instructed to consult a doctor if there is any redness or swelling in the painful area or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is crucial to inform patients that the risk of heart attack or stroke may increase if the medication is used in excess of the recommended dosage or for a duration longer than directed.

Healthcare providers should encourage patients to consult a doctor before use if the child has experienced problems or serious side effects from pain relievers or fever reducers in the past. They should also be advised to seek medical advice if the stomach bleeding warning is applicable to their child, or if the child has a history of stomach issues, such as heartburn.

Patients should be counseled to consult a doctor before use if the child has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, or has underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, it is important to advise patients to seek medical advice if the child has asthma, is taking a diuretic, or is under a doctor's care for any serious condition. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if the child is taking any other medications.

Storage and Handling

The product is supplied in a container that requires careful handling to ensure its integrity and effectiveness. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Prior to use, the product must be shaken well to ensure proper mixing.

For accurate dosing, only the enclosed measuring cup should be utilized. It is imperative to inspect the product before use; do not use if the bottle wrap or the imprinted foil inner seal is broken or missing. To maintain child resistance, the original bottle cap must be replaced after each use.

Additionally, it is important to retain the carton, as it contains essential information regarding the product. Users should refer to the end panel for the expiration date to ensure the product is used within its effective period.

Additional Clinical Information

The product is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to shake the bottle well before use and to utilize the enclosed measuring cup for accurate dosing, preferably based on weight; if weight is not available, age may be used instead. It is important to replace the original bottle cap to ensure child resistance and to store the product at temperatures between 20° to 25°C (68° to 77°F). Patients should be cautioned against using the product if the bottle wrap or imprinted foil inner seal is broken or missing.

Additionally, it is noted that the product does not contain complete directions or warnings for adult use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.