Ibuprofen

Description

MAJOR® is an oral suspension formulation of Ibuprofen specifically designed for infants aged 6 months to 23 months. Each 1.25 mL dose contains 50 mg of Ibuprofen, serving as a nonsteroidal anti-inflammatory drug (NSAID) for pain relief and fever reduction. The effects of the medication can last up to 8 hours. This product is available in a concentrated drop form and is flavored with berry to enhance palatability. Administration is facilitated through the use of the enclosed syringe. The total volume of the product is 0.5 fluid ounces (15 mL) and is comparable to the active ingredient found in MOTRIN® INFANTS’ DROPS.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should ensure that dosing is based on the child's weight whenever possible. If weight is not available, age may be used as a guide.

Prior to administration, the product must be shaken well. The appropriate dose should be measured using the dosing device provided; no other measuring device should be utilized to ensure accuracy.

For children under 6 months of age, it is advised to consult a physician before administration. For children weighing between 12 to 17 pounds (approximately 6 to 11 months), the recommended dose is 1.25 mL. For those weighing between 18 to 23 pounds (approximately 12 to 23 months), the recommended dose is 1.875 mL.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek to facilitate swallowing. If necessary, doses may be repeated every 6 to 8 hours, but it is imperative not to exceed 4 doses in a 24-hour period. Healthcare professionals should emphasize to caregivers the importance of adhering to these guidelines and not exceeding the recommended 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 in the perioperative period surrounding heart surgery due to potential complications.

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 use.

Additionally, NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

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 ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless directed by a healthcare provider.

Healthcare professionals should advise caregivers to consult a physician prior to use 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, kidney disease, or a history of stroke, has asthma, or is taking a diuretic. Furthermore, it is advisable to consult a doctor or pharmacist 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.

Caregivers should discontinue use and consult a physician if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. 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.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen is associated with an increased risk of severe 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 guidelines.

Additionally, ibuprofen carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used inappropriately, such as exceeding the recommended dosage or duration of treatment.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical advice promptly.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt consultation with a healthcare provider.

Before using ibuprofen, it is essential for patients to 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. Patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should also seek medical advice prior to use. Additionally, patients with asthma or those taking diuretics should consult a healthcare provider before using this medication.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to patients with such allergies.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further amplified when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen.

Given these interactions, it is advisable for healthcare providers to closely monitor patients who are prescribed ibuprofen, especially those who are concurrently using anticoagulants, steroids, or other NSAIDs. Additionally, consultation with a healthcare professional is recommended if the patient is taking any other medications, to ensure safe and effective use of ibuprofen.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. The recommended dosing for pediatric patients aged 6 months to 23 months is as follows: for those weighing 12-17 lbs (approximately 6-11 months of age), the dose is 1.25 mL; for those weighing 18-23 lbs (approximately 12-23 months of age), the dose is 1.875 mL.

Healthcare professionals should advise caregivers to consult a doctor if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea. Additionally, if any signs of stomach bleeding occur—such as faintness, vomiting blood, bloody or black stools, or persistent stomach pain—the medication should be discontinued, and medical advice sought immediately.

Caregivers should also be vigilant for symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, and seek medical assistance if these symptoms arise. If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond 3 days, a healthcare professional should be consulted.

Geriatric Use

Geriatric patients may not have specific use information provided in the prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for elderly patients. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes that may affect drug metabolism and response. Regular monitoring and assessment of therapeutic outcomes are advised to ensure safety and efficacy in this population.

Pregnancy

The use of ibuprofen during pregnancy is generally not recommended. It is contraindicated in the third trimester due to the risk of premature closure of the ductus arteriosus in the fetus. There is a potential risk of fetal harm associated with ibuprofen use, particularly in the later stages of pregnancy. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may be linked to adverse effects on fetal development.

Healthcare providers should consider dosage modifications as necessary and advise pregnant patients to consult with them prior to using ibuprofen. It is essential for pregnant women to discuss the potential benefits and risks of ibuprofen with their healthcare provider to make an informed decision regarding its use during pregnancy.

Lactation

Nursing mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes ibuprofen.

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 medication 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 is recommended throughout the treatment course to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate treatment plan and monitoring strategy.

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 the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No teratogenic effects were reported in the conducted studies. Adverse developmental outcomes were not observed in animal studies, indicating a lack of significant developmental toxicity associated with the compound.

In animal studies, ibuprofen did not cause an increase in fetal malformations. Furthermore, studies indicated that ibuprofen did not adversely affect reproductive performance in animals.

No specific nonclinical toxicology data were provided.

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 should be considered when evaluating the safety profile of the product.

Patient Counseling

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

Patients should be instructed to stop using the medication 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 stomach pain that does not improve. Additionally, 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, they should also discontinue use and seek medical advice.

It is important to inform patients that if the child does not experience any relief within the first 24 hours of treatment, they should stop using the product and consult a doctor. Furthermore, if fever or pain worsens or persists for more than three days, or if there is any redness or swelling in the painful area, medical advice should be sought. Patients should also be aware that any new symptoms that arise warrant a consultation with a healthcare professional.

When administering this product, it is recommended to give it with food or milk if the child experiences stomach upset. Patients should be encouraged to consult a doctor before use if any of the following 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, kidney disease, or a history of stroke; has asthma; or is taking a diuretic.

Lastly, 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 configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Freezing is not permitted, as it may compromise the product's quality. Additionally, the product must not be used if the printed neckband is broken or missing, ensuring that the integrity of the packaging is intact before use.

Additional Clinical Information

The medication is administered orally, with clinicians advised to dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. If necessary, the dose may be repeated every 6 to 8 hours, but it should not be used more than four times a day.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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)