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Ibuprofen

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 1999
Label revision date
May 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 1999
Label revision date
May 12, 2025
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Registration number
ANDA074937
NDC root
17856-5309
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (9 NDCs)
Packaging & NDC Codes (9)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Ibuprofen suspension is a medication that helps relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headache, and toothache. It is also effective in reducing fever, making it a useful option for managing discomfort associated with various illnesses.

This medication is designed to provide you with relief when you need it, helping you feel more comfortable during times of illness or discomfort.

Uses

You can use this medication to help relieve minor aches and pains that may come from common conditions like the cold, flu, sore throat, headache, or 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 are pregnant, although you should always consult with your healthcare provider before taking any medication.

Dosage and Administration

Before using this product, make sure to shake the bottle well. It's important to follow the dosing chart to find the right amount for you or your child. If possible, use weight to determine the dose; if not, you can use age. Always use the enclosed dosing cup to measure the medicine—other devices may not give you the correct amount.

For most cases, you can repeat the dose every 6 to 8 hours, but do not take more than four doses in a single day. After each use, wash the dosing cup to keep it clean. Remember to replace the original bottle cap to keep it child-resistant. If your child weighs less than 24 pounds or is under 2 years old, it's best to consult a doctor for the appropriate dose.

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 longer than recommended can 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 a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication 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 (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

If your child experiences symptoms such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, you should stop use and consult a doctor immediately. It's also important to seek medical advice if your child does not find relief within 24 hours, if fever or pain worsens or lasts more than three days, or if any new symptoms arise. Always consult a doctor before use if your child has a history of stomach issues, is dehydrated, or has other serious health conditions.

Warnings and Precautions

It's important to be aware of some serious warnings when using ibuprofen. If you or your child have a known allergy to aspirin, be cautious, as ibuprofen can cause severe allergic reactions. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If any of these occur, stop using the medication and seek medical help immediately. Additionally, ibuprofen can lead to severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

Before using ibuprofen, consult a doctor if your child has any history of stomach problems, is dehydrated, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also wise to check with a healthcare professional if your child is under treatment for a serious condition or is taking other medications. If you suspect an overdose, contact a Poison Control Center or seek medical help right away.

You should stop using ibuprofen and call your doctor if your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or if stomach pain persists. Additionally, if there is no relief within 24 hours, or if fever or pain worsens or lasts more than three days, it's important to reach out to a healthcare provider.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

It’s important to be cautious when considering the use of this product during pregnancy. You should not use it if the printed neckband is broken or missing. Additionally, avoid using it for more than two days or giving it to children under three years old unless your doctor specifically advises you to do so. If your child is under a doctor’s care for any serious condition, consult with a healthcare professional before using this product.

Be aware that using this product for longer than recommended or in higher doses may increase the risk of serious health issues, such as heart attack or stroke. Remember, this product does not provide complete instructions or warnings for adult use, so it’s essential to discuss any concerns with your healthcare provider.

Lactation Use

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

Pediatric Use

When considering this medication for your child, it's important to follow specific guidelines. Do not use it for more than 2 days or give it to children under 3 years old unless directed by a doctor. Dosing varies by weight and age, so refer to the chart: for children under 24 lbs (under 2 years), consult a doctor; for those weighing 24-35 lbs (2-3 years), the dose is 5 mL (1 teaspoon); and it increases with weight and age up to 15 mL (3 teaspoons) for children weighing 72-95 lbs (11 years).

Before administering, check with a doctor if your child has had allergic reactions to pain relievers, is under care for serious conditions, or is taking other medications. It's also wise to consult if your child has a history of stomach issues, dehydration, or chronic health problems like asthma or heart disease. If your child shows signs of stomach bleeding, worsening symptoms, or does not improve within 24 hours, stop use and seek medical advice immediately.

Geriatric Use

When considering this product for older adults, it's important to consult with a doctor first, especially if you or your loved one has any existing health conditions such as high blood pressure, heart disease, liver cirrhosis (a serious liver condition), or kidney disease. These conditions can affect how the body processes medications and may require special attention or adjustments in dosage.

Keep in mind that this product does not provide complete warnings or directions specifically for adult use, so professional guidance is essential to ensure safety and effectiveness. Always prioritize open communication with healthcare providers to address any concerns or questions regarding medication use.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your healthcare provider will help determine if it's safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a serious condition where the liver becomes severely scarred), it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or closely monitor your liver function tests (tests that check how well your liver is working) to ensure your safety and the effectiveness of your treatment.

Additionally, if you have other health issues like high blood pressure or heart disease, these can also influence how your liver functions and how medications are processed in your body. Always communicate openly with your healthcare team about your liver condition and any other health concerns you may have.

Drug Interactions

It's important to be aware of potential interactions when taking ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to a severe allergic reaction. Additionally, if your child is on blood thinners (medications that prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Using ibuprofen for longer than recommended or at higher doses can raise the chances of serious issues like heart attack or stroke. If your child has asthma and is taking a diuretic (a medication that helps remove excess fluid), it's crucial to consult a healthcare provider. Always discuss any medications or tests with your doctor to ensure safety and effectiveness.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can affect its effectiveness. Additionally, make sure to check the bottom panel for the lot number and expiration date, as this information is crucial for confirming the product's safety and usability.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. If you experience stomach upset, it's advisable to take the medication with food or milk.

Make sure to keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Ibuprofen Suspension used for?

Ibuprofen Suspension 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 Ibuprofen Suspension for my child?

Use the enclosed dosing cup and find the right dose on the chart based on your child's weight or age. Do not exceed the recommended dose.

What should I do if my child experiences stomach upset?

If stomach upset occurs, give Ibuprofen Suspension with food or milk.

What are the signs of a severe allergic reaction to Ibuprofen?

Signs may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Seek medical help immediately if these occur.

What should I do if my child shows signs of stomach bleeding?

Stop use and call a doctor if your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve.

Can I use Ibuprofen Suspension if my child has had an allergic reaction to other pain relievers?

No, do not use Ibuprofen Suspension if your child has ever had an allergic reaction to any other pain reliever or fever reducer.

How should I store Ibuprofen Suspension?

Store Ibuprofen Suspension at 20-25°C (68-77°F) and do not freeze.

Is it safe to use Ibuprofen Suspension for more than 2 days?

Do not use Ibuprofen Suspension for more than 2 days or administer it to children under 3 years of age unless directed by a doctor.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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

Ibuprofen Suspension is a pharmaceutical formulation designed for oral administration. It contains ibuprofen as the active ingredient, which is a nonsteroidal anti-inflammatory drug (NSAID) used for its analgesic, antipyretic, and anti-inflammatory properties. The suspension is intended for use in the management of pain and fever. The effective date for this formulation is December 12, 2023.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

For patients weighing under 24 lbs or under 2 years of age, it is advised to consult a physician for the appropriate dosage. For patients weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL (1 teaspoonful). For those weighing 36-47 lbs (ages 4-5 years), the dose is 7.5 mL (1½ teaspoonfuls). Patients weighing 48-59 lbs (ages 6-8 years) should receive 10 mL (2 teaspoonfuls), while those weighing 60-71 lbs (ages 9-10 years) should be administered 12.5 mL (2½ teaspoonfuls). For patients weighing 72-95 lbs (age 11 years), the recommended dose is 15 mL (3 teaspoonfuls).

Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period. After each use, the dosing cup should be washed thoroughly. To maintain child resistance, the original bottle cap must be replaced securely after each use. It is critical to adhere to the recommended dosing guidelines and not exceed the directed amount.

Contraindications

Use is contraindicated in the following situations:

  • In patients with a history of allergic reactions to any other pain reliever or fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, 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 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 increased in children who have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or are exceeding the recommended dosage or duration of treatment.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. The use of this medication should not exceed two days, and it should not be administered to children under three years of age unless directed by a healthcare provider.

Before administering ibuprofen, it is advisable to consult a physician if any of the following conditions apply: the child has a history of stomach problems (such as heartburn), has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, or kidney disease, has asthma, or is taking a diuretic. Additionally, consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Parents and caregivers should discontinue use and contact a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, failing to achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days. Additionally, any redness or swelling in the painful area or the emergence of new symptoms warrants immediate medical consultation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

Additionally, the use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. Patients are advised to adhere strictly to dosing instructions, as prolonged use or exceeding recommended dosages may elevate this risk.

Common adverse reactions may include gastrointestinal symptoms. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients should discontinue use and seek medical attention promptly.

Furthermore, patients should consult a healthcare provider if they do not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Before using this product, it is recommended that patients consult a healthcare professional if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Special caution is advised for patients with conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as for those who are dehydrated or taking diuretics.

In summary, while this product can be effective for pain relief, patients should be aware of the potential for serious and common adverse reactions and should seek medical advice when necessary.

Drug Interactions

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

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

Gastrointestinal Risks The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. This risk is further elevated when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen. Monitoring for signs of gastrointestinal distress is advised in patients receiving these combinations.

Cardiovascular Risks The use of ibuprofen in doses exceeding the recommended guidelines or for durations longer than prescribed may elevate the risk of cardiovascular events, including heart attack and stroke. It is advisable to adhere strictly to dosing recommendations and to evaluate the necessity of continued therapy regularly.

Diuretic Considerations In pediatric patients with asthma who are prescribed diuretics, consultation with a healthcare provider is recommended prior to initiating ibuprofen therapy. This is to ensure that potential interactions and exacerbations of asthma symptoms are adequately managed.

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 should not use this medication for more than 2 days or be administered to children under 3 years of age unless directed by a healthcare professional.

Dosing recommendations are as follows:

  • For children under 24 lbs (under 2 years), consult a doctor.

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

  • For children weighing 36-47 lbs (4-5 years), the recommended dose is 7.5 mL (1½ tsp).

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

  • For children weighing 60-71 lbs (9-10 years), the recommended dose is 12.5 mL (2½ tsp).

  • For children weighing 72-95 lbs (11 years), the recommended dose is 15 mL (3 tsp).

  • Dosage may also be directed by a healthcare professional.

Before use, it is essential to consult a doctor if the child has a history of allergic reactions to any pain reliever or fever reducer. Additionally, consultation is advised if the child is under a doctor's care for any serious condition, taking other medications, has a history of stomach issues (e.g., heartburn), has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, has asthma, or is taking a diuretic.

Parents and caregivers should discontinue use and seek medical advice if the child exhibits any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, not achieving relief within the first 24 hours of treatment, worsening fever or pain lasting more than 3 days, redness or swelling in the painful area, or any new symptoms.

Geriatric Use

Elderly patients should exercise caution when considering the use of this product, as it does not contain specific directions or complete warnings for adult use. It is imperative for healthcare providers to assess the individual health status of geriatric patients prior to administration.

Particular attention should be given to those elderly patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is advisable for these patients to consult with a healthcare professional before using the product to ensure safety and appropriateness of use. Monitoring for potential adverse effects and interactions is recommended in this population.

Pregnancy

Pregnant patients should be advised against using this product if the printed neckband is broken or missing. The safety of this product during pregnancy has not been established, and it is recommended that pregnant patients consult their healthcare provider before use, particularly if they have any serious medical conditions or are under a doctor's care.

The product is not intended for use beyond 2 days or in children under 3 years of age unless directed by a physician. There is a potential risk of adverse cardiovascular events, such as heart attack or stroke, associated with the use of this product if used in excess of the recommended duration or dosage. Therefore, healthcare professionals should exercise caution and ensure that pregnant patients are informed of these risks and the importance of adhering to the recommended guidelines.

Lactation

Lactating mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. Caution is advised when administering ibuprofen to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended throughout the treatment course.

Additionally, patients with a history of liver disease, such as cirrhosis, should be evaluated for any concurrent conditions, including high blood pressure and heart disease, as these may further complicate management and necessitate additional precautions.

Healthcare providers should exercise caution and consider the overall clinical picture when prescribing this medication to patients with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients 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, patients should be cautioned against using this product right before or after heart surgery.

Patients must be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, not achieving relief within the first 24 hours of treatment, or if fever or pain worsens or lasts more than three days. They should also be aware that redness or swelling in the painful area or the appearance of any new symptoms warrants medical consultation.

When administering this product, it is recommended to give it with food or milk if the child experiences stomach upset. Patients should be made aware that exceeding the directed dosage or duration of use may increase the risk of heart attack or stroke.

Healthcare providers should encourage patients to consult a doctor before use if any of the following apply: the child has a history of stomach bleeding, has experienced stomach problems such as heartburn, has had serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, or kidney disease, has asthma, or is taking a diuretic.

Furthermore, patients should be advised to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. For reference, the lot number and expiration date are located on the bottom panel of the packaging, ensuring proper tracking and usage within the recommended timeframe.

Additional Clinical Information

The medication is administered orally, with the option to repeat doses every 6-8 hours as needed, not exceeding four doses in a 24-hour period. Clinicians should advise patients to take the medication with food or milk if they experience stomach upset.

It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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

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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.