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Pain and Fever

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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 2019
Label revision date
June 12, 2024
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 2019
Label revision date
June 12, 2024
Manufacturer
Walgreens
Registration number
M013
NDC root
0363-9380
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 belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is designed for children aged 2 to 11 years and 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, providing comfort during illness.

This medication is available in a grape flavor and is alcohol-free, making it suitable for children. Each dose lasts up to 8 hours, and a dosage cup is included for easy measurement. Ibuprofen is comparable to the active ingredient found in Children's Motrin®, but it is not manufactured or distributed by McNeil Consumer Healthcare.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, or toothache. It is 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.

Dosage and Administration

Before using this product, 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 the enclosed dosing cup for accurate measurement—do not use any other device. 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 who weigh less than 24 pounds, it’s best to consult a doctor for the appropriate dose. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the dose is 5 mL. If your child is 4 to 5 years old and weighs between 36 and 47 pounds, the dose increases to 7.5 mL. For those aged 6 to 8 years weighing 48 to 59 pounds, the dose is 10 mL, and for children aged 9 to 10 years weighing 60 to 71 pounds, it’s 12.5 mL. Finally, for an 11-year-old weighing between 72 and 95 pounds, the dose is 15 mL. Always replace the original bottle cap after use to keep it child-resistant.

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 in children with a history of stomach ulcers or those taking blood thinners or other NSAIDs (nonsteroidal anti-inflammatory drugs). 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 there are 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 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 in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or skin rash, stop using the medication immediately and seek medical help. Additionally, be aware that ibuprofen can lead to stomach bleeding, particularly 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. Always follow the recommended dosage to minimize risks.

There are also important warnings regarding heart health. Using ibuprofen can increase the risk of heart attack and stroke, especially if taken in higher doses or for longer than recommended. If your child experiences severe sore throat symptoms, such as a high fever or persistent pain, consult a doctor right away.

If you suspect an overdose, contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help. You should also stop using ibuprofen and consult a doctor if your child shows signs of stomach bleeding (like faintness or bloody stools), heart problems (such as chest pain or trouble breathing), or if symptoms do not improve within 24 hours. If fever or pain worsens or lasts more than three days, or if new symptoms arise, it’s important to seek medical advice.

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

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no contraindications (conditions that would prevent its use) mentioned, and no dosage adjustments are recommended for pregnant individuals. Additionally, the text does not highlight any special precautions you should take if you are pregnant.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that ibuprofen may pass into your breast milk, which could pose some risks to your baby. Therefore, you should exercise caution when considering ibuprofen while nursing. Always prioritize your health and your infant's safety by seeking professional guidance.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it in children under 3 years of age 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 and is under 2 years old, consult a doctor first. For children aged 2-3 years who weigh between 24-35 pounds, the recommended dose is 5 mL, while those aged 4-5 years and weighing 36-47 pounds should take 7.5 mL. As the weight increases, so does the dosage, reaching up to 15 mL for an 11-year-old weighing 72-95 pounds.

Always consult a doctor if your child has a history of stomach issues, is not drinking enough fluids, has lost fluids from vomiting or diarrhea, or has conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. If your child shows signs of stomach bleeding, heart problems, or stroke, or if their symptoms worsen or do not improve within 24 hours, stop using the medication and seek medical advice immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 other medical conditions you may have.

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 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 the treatment.

Additionally, if you have other health conditions like high blood pressure, heart disease, or kidney disease, these may also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical issues you may have.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For instance, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. This risk is even greater if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are also being used.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20º to 25ºC (68º to 77ºF). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safety and compliance with local regulations.

Additional Information

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

Be alert for serious side effects. If your child shows any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, stop the medication and consult a doctor. Additionally, seek medical attention if your child exhibits symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. If there is no relief within 24 hours, if fever or pain worsens or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms appear, contact a healthcare professional.

FAQ

What is ibuprofen used for?

Ibuprofen is used to relieve minor aches and pains due to common cold, flu, sore throat, headache, and toothache, as well as to reduce fever.

What age group can use ibuprofen?

Ibuprofen is intended for children ages 2 to 11 years.

How long does the effect of ibuprofen last?

The effects of ibuprofen can last up to 8 hours.

What should I do if my child has a history of stomach problems?

Consult a doctor before using ibuprofen if your child has a history of stomach problems, such as ulcers or bleeding.

How should ibuprofen be administered?

Ibuprofen should be taken orally, and you should use only the enclosed dosing cup to measure the dose.

What are the dosing recommendations for ibuprofen?

Dosing varies by weight and age; for example, a child weighing 24-35 lb and aged 2-3 years should take 5 mL.

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

Stop using ibuprofen and consult a doctor if your child experiences symptoms like faintness, vomiting blood, or black stools.

Can ibuprofen be used during pregnancy?

The provided information does not specify any risks or contraindications for using ibuprofen during pregnancy.

Is ibuprofen safe for nursing mothers?

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

What should I do if my child has an allergic reaction to ibuprofen?

If an allergic reaction occurs, stop use immediately and seek medical help right away.

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

Ibuprofen is an oral suspension, classified as a nonsteroidal anti-inflammatory drug (NSAID), formulated to provide pain relief and reduce fever. Each 5 mL of the suspension contains 100 mg of ibuprofen. The product is designed for oral administration and is alcohol-free, featuring a grape flavor for palatability. A dosage cup is included for accurate measurement. The formulation is tamper evident; it should not be used if the printed neckband is broken or missing. The effects of ibuprofen can last up to 8 hours.

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 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.

Prior to administration, the product must be shaken well. The enclosed dosing cup should be utilized exclusively for measuring the dose; no other dosing devices should be employed.

The recommended dosing is as follows:

  • For patients weighing less than 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

  • For patients weighing between 24-35 lb or aged 2-3 years, the dose is 5 mL.

  • For patients weighing between 36-47 lb or aged 4-5 years, the dose is 7.5 mL.

  • For patients weighing between 48-59 lb or aged 6-8 years, the dose is 10 mL.

  • For patients weighing between 60-71 lb or aged 9-10 years, the dose is 12.5 mL.

  • For patients weighing between 72-95 lb or aged 11 years, the dose is 15 mL.

If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed four doses.

To maintain child resistance, the original bottle cap should be replaced after each use. It is imperative that the product is not administered in excess of the directed dosage.

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 an extended period.

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. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Healthcare professionals should advise caregivers to discontinue use and consult a physician 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 advice should be sought promptly.

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 extended periods beyond the recommended duration.

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 for longer than directed.

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 suggestive 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.

It is advised to discontinue use and consult a doctor 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 painful area, or if any new symptoms arise.

Before administering ibuprofen, it is crucial to consult a healthcare professional if the child has a history of stomach issues, 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 a history of stroke. Additionally, children with asthma or those taking diuretics should seek medical advice prior to use.

Patients under a doctor's care for any serious condition or those taking other medications should also consult a healthcare provider before using ibuprofen.

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or steroid medications. This risk is particularly pronounced in pediatric patients who may also be taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, or naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen in conjunction with these drug classes. Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the patient's overall medication regimen and clinical status.

No specific interactions with laboratory tests 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 healthcare professional. For dosing, the following guidelines apply:

  • For patients weighing under 24 lb and under 2 years of age, consultation with a doctor is required.

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

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

  • For children weighing 48-59 lb and aged 6-8 years, the dose is 10 mL.

  • For those weighing 60-71 lb and aged 9-10 years, the dose is 12.5 mL.

  • For patients weighing 72-95 lb and aged 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 not adequately hydrated, has experienced significant fluid loss due to vomiting or diarrhea, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma.

Parents or guardians should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding, symptoms indicative of heart problems or stroke, does not achieve relief within the first 24 hours of treatment, experiences worsening fever or pain lasting more than 3 days, shows redness or swelling in the affected area, or develops any new symptoms.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The text does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. 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 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 may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of significant liver disease, such as cirrhosis, should be evaluated for potential contraindications and may require more frequent clinical assessments to monitor for any signs of hepatic decompensation. It is crucial to tailor treatment plans based on the severity of hepatic impairment to optimize outcomes while minimizing risks.

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 in mitigating potential adverse effects associated with overdose. Symptoms 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 and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

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

Additionally, there have been cases of cardiovascular events, including heart attack and stroke. Reports of allergic reactions, such as anaphylaxis and angioedema, have been received. Instances of elevated blood pressure in patients taking ibuprofen have been noted, along with reports of dizziness and headache as side effects. Furthermore, gastrointestinal perforation has been reported, particularly in patients with a history of gastrointestinal issues.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (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 medication right before or after heart surgery.

Patients should be instructed to stop 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, or experiencing persistent stomach pain. Furthermore, healthcare providers should emphasize the importance of discontinuing use and seeking medical advice if the 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.

Patients should also be informed to stop use and consult a doctor 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 there is redness or swelling in the painful area, or if any new symptoms arise.

When administering this product, patients should be advised to take it with food or milk if stomach upset occurs. It is important for healthcare providers to recommend that patients 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 encouraged to seek medical advice if the 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.

Healthcare providers should also recommend that patients consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. If the child has asthma, is taking a diuretic, or is under a doctor's care for any serious condition, patients should be advised to consult a doctor or pharmacist prior to use. Lastly, it is essential for patients to discuss any other medications their child is taking with a healthcare professional before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20º to 25ºC (68º to 77ºF) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients should be advised that 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. It is recommended to take the medication with food or milk if stomach upset occurs.

Clinicians should counsel patients to monitor for serious side effects, including signs of stomach bleeding such as faintness, vomiting blood, bloody or black stools, and persistent stomach pain. Additionally, they should be alert for symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling. Patients should seek medical attention if there is no relief within the first 24 hours, 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.

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.