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Pain and Fever

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This product has been discontinued

Active ingredient
Ibuprofen 100 mg/1 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 2023
Label revision date
March 15, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/1 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 2023
Label revision date
March 15, 2023
Manufacturer
CVS PHARMACY, INC
Registration number
part343
NDC root
51316-938
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 is an oral suspension medication that contains 100 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 5 mL. It is commonly used to relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, ibuprofen helps reduce fever, making it a versatile option for managing discomfort in children aged 2 to 11.

This medication is designed to provide relief for up to 8 hours and comes in a pleasant grape flavor, making it easier for children to take. It is important to follow the recommended dosage, and a dosage cup is included for your convenience.

Uses

You can use this medication to help relieve minor aches and pains caused by various conditions, such as the common cold, flu, sore throat, headache, and toothache. Additionally, it is 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.

Dosage and Administration

Before using this medication, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to shake the bottle well before each use. When measuring your dose, use only the enclosed dosing cup, as other devices may not provide the correct amount.

For children, the dose depends on their weight and age. For example, if your child weighs between 24 and 35 pounds and is aged 2 to 3 years, the recommended dose is 5 mL. If your child weighs between 36 and 47 pounds and is aged 4 to 5 years, the dose increases to 7.5 mL. You can repeat the dose every 6 to 8 hours if needed, but do not exceed 4 doses in a single day. Always remember to replace the original bottle cap after use to keep it safe from children. If your child weighs less than 24 pounds and is under 2 years old, 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 ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after your child has undergone heart surgery. Following these guidelines will help ensure your child's safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, especially in individuals who are allergic to aspirin. Symptoms of a severe allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of stomach bleeding, particularly 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. The risk of heart attack and stroke is also increased with NSAID use, especially if taken in higher doses or for longer than recommended.

You should stop using ibuprofen and consult a doctor if your child experiences signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools. Seek medical attention if they show symptoms of heart problems or stroke, like chest pain or weakness on one side of the body. If your child does not find relief within 24 hours, or if their fever or pain worsens or lasts more than three days, it's important to contact a healthcare professional. 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

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 can also lead to 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 (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop use and contact your doctor right away.

If you or your child has a severe sore throat that lasts more than two days or is accompanied by high fever, headache, nausea, or vomiting, consult a doctor. For any overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222. Always monitor for worsening symptoms or new issues, and if relief is not achieved within 24 hours, reach out to your 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.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

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. These risks can include potential heart problems and kidney issues for the fetus.

Before taking ibuprofen or any medication, you should always consult your healthcare provider. They can help you understand the safest options for managing pain or discomfort during your pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which could pose risks to your infant. Therefore, exercise caution when considering this product while nursing, as it may affect both your milk production and your baby's health. Always prioritize open communication with your healthcare provider to ensure the best outcomes for you and your child.

Pediatric Use

It's important to be cautious when using this medication for children. You should not give it to children under 3 years old unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage depends on their weight. For example, if your child weighs under 24 pounds (less than 2 years), consult a doctor first. If they weigh between 24-35 pounds (2-3 years), the recommended dose is 5 mL, and it increases with weight up to 15 mL for those who weigh 72-95 pounds (11 years).

Always consult a doctor if your child has a history of stomach issues, is taking other medications, or isn't drinking enough fluids. You should not use this medication for more than 2 days, and if your child does not feel better within 24 hours, or if their fever or pain worsens or lasts more than 3 days, stop using it and seek medical advice.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available regarding its use. This means that there are no recommended age-related considerations, dosage adjustments, or safety concerns specifically for elderly patients.

As always, it's important for you or your caregiver to discuss any medications with your healthcare provider, especially if you have any underlying health conditions or are taking other medications. Your doctor can help ensure that any treatment plan is safe and effective for your individual needs.

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, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or additional monitoring based on your specific health needs. Always prioritize open communication with your doctor regarding your kidney health and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware that this product contains a nonsteroidal anti-inflammatory drug (NSAID), which can increase the risk of stomach bleeding, especially if your child is also taking blood thinners (medications that prevent blood clots) or steroids. Additionally, if your child is using other NSAIDs, such as aspirin, ibuprofen, or naproxen, the risk may be even higher.

Always discuss any medications your child is taking with their healthcare provider to ensure safety and avoid potential interactions. While there are no specific laboratory test interactions noted, keeping your healthcare provider informed about all medications is crucial for effective and safe treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20º to 25ºC (68º to 77ºF). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to keep it in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and compliance.

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 help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that helps relieve minor aches and pains due to common cold, flu, sore throat, headache, and toothache.

What is the recommended dosage for children?

The dosage varies by weight and age. For example, children weighing 24-35 lb (ages 2-3) should take 5 mL, while those weighing 72-95 lb (age 11) should take 15 mL.

How often can I give ibuprofen to my child?

You can repeat the dose every 6-8 hours, but do not use more than 4 times a day.

Are there any warnings associated with ibuprofen?

Yes, ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can ibuprofen be used during pregnancy?

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

What should I do if my child experiences symptoms of stomach bleeding?

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and consult a doctor immediately.

Is there a specific way to administer ibuprofen?

Yes, you should use the enclosed dosing cup and shake well before using. Take with food or milk if stomach upset occurs.

What should I do in case of an overdose?

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

How should ibuprofen be stored?

Store ibuprofen between 20º to 25ºC (68º to 77ºF) and keep it out of reach of children.

Can nursing mothers use ibuprofen?

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

Packaging Info

Below are the non-prescription pack sizes of Pain and Fever (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain and Fever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Ibuprofen Oral Suspension is formulated to provide pain relief and reduce fever, containing 100 mg of ibuprofen per 5 mL. This nonsteroidal anti-inflammatory drug (NSAID) is designed for pediatric use and is presented in a grape flavor. The suspension is free from added alcohol and is effective for up to 8 hours. A dosage cup is included for accurate measurement. The product features a tamper-evident seal; it should not be used if the printed neckband is broken or missing. This product is distributed by CVS Pharmacy, Inc., located at One CVS Drive, Woonsocket, RI 02895.

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

This product is intended for use in pediatric patients, and specific dosing should be determined based on weight and age. Healthcare professionals should advise caregivers to consult a doctor for children weighing less than 24 pounds or under 2 years of age.

For children weighing between 24 to 35 pounds and aged 2 to 3 years, the recommended dose is 5 mL. For those weighing 36 to 47 pounds and aged 4 to 5 years, the dose increases to 7.5 mL. Children weighing 48 to 59 pounds and aged 6 to 8 years should receive 10 mL. For children weighing 60 to 71 pounds and aged 9 to 10 years, the appropriate dose is 12.5 mL. Finally, for children weighing 72 to 95 pounds and aged 11 years, the recommended dose is 15 mL.

Dosing may be repeated every 6 to 8 hours as needed, but should not exceed four doses in a 24-hour period. It is imperative to use only the enclosed dosing cup for administration; other dosing devices are not recommended. Prior to use, the product must be shaken well to ensure proper mixing. After each use, the original bottle cap should be replaced to maintain child resistance. Caregivers should be instructed to adhere strictly to the dosing guidelines and not exceed the recommended amounts.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

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 is associated with an increased risk of stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

NSAIDs, excluding aspirin, are also linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised in such cases. Additionally, ibuprofen should not be used for more than two days or administered to children under three years of age unless specifically directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Contact a Poison Control Center at 1-800-222-1222 without delay.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice if the child exhibits any of the following signs indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical evaluation. Furthermore, if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical consultation is strongly recommended.

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.

The use of ibuprofen is associated with an increased risk of stomach bleeding, particularly in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs (including aspirin, ibuprofen, or naproxen). The risk of stomach bleeding is heightened if the medication is taken in higher doses or for longer durations than recommended.

Additionally, ibuprofen carries warnings regarding the potential for heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or duration.

Patients should be vigilant for signs of serious conditions. If a child experiences symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, medical attention should be sought immediately. Symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, also warrant prompt consultation with a healthcare provider.

Common adverse reactions may include a sore throat, especially if it is severe or persistent, or accompanied by high fever, headache, nausea, and vomiting. In such cases, it is advised to consult a doctor promptly and to limit use to no more than two days without medical guidance, particularly for children under three years of age.

Patients should discontinue use and seek medical advice if there is no relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using ibuprofen, it is recommended to consult a healthcare provider if the child has a history of stomach problems, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, consultation is advised if the child is taking diuretics or is under a doctor's care for any serious condition.

Drug Interactions

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of gastrointestinal bleeding. This risk is particularly heightened in patients who are concurrently using anticoagulants or steroid medications. Additionally, the concomitant use of other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, may further elevate this risk.

Healthcare professionals should exercise caution when prescribing this NSAID to patients who are on blood thinners or steroids, and it may be advisable to monitor these patients closely for signs of gastrointestinal complications. No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Pain and Fever (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain and Fever.
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 based on weight:

  • For patients weighing under 24 lb (under 2 years), consultation with a doctor is required.

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

  • For patients weighing 36-47 lb (4-5 years), the dose is 7.5 mL.

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

  • For patients weighing 60-71 lb (9-10 years), the dose is 12.5 mL.

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

Healthcare professionals should advise parents or guardians to consult a doctor if the child has a history of stomach problems, is taking other medications, or has not been drinking fluids. The medication should not be used for more than 2 days, and if the child does not experience relief within the first 24 hours, or if fever or pain worsens or lasts more than 3 days, or if any new symptoms appear, a doctor should be contacted immediately.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age-related considerations. There are no recommended dosage adjustments or safety concerns outlined for geriatric patients. Additionally, no special precautions are indicated for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

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 nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, during pregnancy may be associated with adverse fetal outcomes, including potential cardiovascular effects and renal impairment.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss the potential risks and benefits. It is essential for healthcare professionals to consider these factors when prescribing medications to pregnant patients.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product 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 a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Clinicians should assess liver enzymes and other relevant parameters regularly to evaluate the patient's response to treatment and to identify any potential adverse effects related to liver function.

It is essential to consider the overall health status of patients, particularly those with comorbid conditions such as high blood pressure, heart disease, kidney disease, or a history of stroke, as these factors may further complicate the management of therapy in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Healthcare providers should ensure that they are prepared to provide supportive care and monitor the patient closely for any adverse effects that may arise from the overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate occurrences of gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented.

Additionally, cases of anaphylactic reactions, such as angioedema and bronchospasm, have been reported. Cardiovascular events, including myocardial infarction and stroke, have been noted in patients using nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, elevated blood pressure has been observed in patients taking ibuprofen. Hepatic reactions, including hepatitis and jaundice, have been included in postmarketing reports.

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 their child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

Patients should be instructed to stop use and consult a doctor if their child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, they should be made aware to discontinue use and seek medical advice if their child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

It is important for healthcare providers to inform patients that if their child does not experience relief within the first 24 hours of treatment, they should stop use and consult a doctor. Patients should also be advised to seek medical attention if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms arise.

When using this product, patients should be encouraged to administer it with food or milk if stomach upset occurs. Healthcare providers should remind patients to consult a doctor before use if the child has a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies. Additionally, patients should be advised to seek medical advice if their child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost significant fluid due to vomiting or diarrhea.

Patients should also be instructed to consult a doctor before use if their child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. It is essential to advise patients to seek medical guidance if their 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 their child is taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20º to 25ºC (68º to 77ºF) to ensure its stability and efficacy. Proper container requirements must be adhered to, and special handling needs should be observed to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Patients are advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Pain and Fever, 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 Pain and Fever, 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.