Motrin Ib

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, menstrual cramps, the common cold, muscular aches, and minor pain of arthritis. Additionally, this drug is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, a dosage of 2 capsules may be administered. It is imperative that the total daily dosage does not exceed 6 capsules within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms 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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries the risk of severe gastrointestinal bleeding. The likelihood of this adverse effect is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use. Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified with prolonged use or higher-than-recommended dosages.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if any of the following conditions apply: a history of stomach bleeding, adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients taking diuretics should also seek medical advice before use. Furthermore, it is essential to inform patients that ibuprofen may diminish the cardioprotective effects of aspirin when taken concurrently for the prevention of heart attack or stroke.

In cases of overdose, immediate medical attention is required. Patients should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of gastrointestinal bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or 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. Patients should also seek medical advice if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in severity.

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, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use ibuprofen in excess of the recommended dosage or for extended periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any symptoms indicative of stomach bleeding or heart problems, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Other concerning signs include worsening pain lasting more than 10 days, fever persisting beyond 3 days, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients to inform their healthcare provider if they are taking diuretics or if they are under care for any serious condition. Furthermore, patients taking aspirin for heart attack or stroke should consult a doctor, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist, with a maximum of 6 capsules in a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications.

Additionally, the risk of heart attack, heart failure, and stroke is elevated in geriatric patients who exceed the recommended dosage or duration of treatment. It is essential for healthcare providers to monitor these patients closely and to adhere strictly to dosing guidelines to mitigate these risks.

Given these safety considerations, healthcare providers should exercise caution when prescribing to elderly patients and consider appropriate dose adjustments and monitoring strategies to ensure optimal safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of gestation unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

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, asthma, 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 should consult a healthcare professional prior to use, particularly if they have liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be necessary to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals 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 support 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

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports indicate occurrences of gastrointestinal bleeding, renal impairment, and cardiovascular events.

Gastrointestinal bleeding has been reported, particularly in patients with a history of gastrointestinal issues. Renal impairment has also been noted, especially among individuals with pre-existing kidney conditions or those experiencing dehydration. Additionally, cardiovascular events, including heart attack and stroke, have been documented, particularly in patients using ibuprofen at higher doses or for extended durations.

Patient Counseling

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

Patients should be informed to take the medication with food or milk if they experience stomach upset. It is important for healthcare providers to encourage patients to consult a doctor before use if they have a history of stomach bleeding or if they have experienced problems or serious side effects from taking pain relievers or fever reducers.

Additionally, patients should be advised to discuss their medical history with their healthcare provider, particularly if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Patients taking diuretics should also be encouraged to consult their doctor before using this medication. Furthermore, healthcare providers should remind patients to speak with their doctor or pharmacist if they are under care for any serious condition or if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin in these cases. Lastly, patients should be advised to inform their healthcare provider or pharmacist about any other medications they are currently taking.

Storage and Handling

The product is supplied in packaging that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity.

Healthcare professionals should ensure that the foil inner seal, which is imprinted with “sealed for your safety,” remains intact. The product should not be used if this seal is broken or missing, as this may compromise safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly critical to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)