Ibuprofen

Description

CVS Ibuprofen Tablets USP contain 200 mg of ibuprofen per tablet. The product is identified by the National Drug Code (NDC) 69842-391-54. These tablets are formulated for oral administration and are designed to provide effective relief from pain and inflammation.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor pain of arthritis, toothache, backache, the common cold, and menstrual cramps. Additionally, it 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 older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets 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 elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions include hives, facial swelling, 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 experiencing 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.

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

Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical consultation is warranted. Patients should also be instructed to report any new symptoms that arise during treatment.

In cases of suspected overdose, immediate medical attention is required. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

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 this NSAID is also associated with an increased 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 use other NSAIDs concurrently. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, if pain persists for more than 10 days or fever lasts more than 3 days, or if redness or swelling occurs in the painful area, patients are advised to discontinue use and consult a healthcare professional.

Furthermore, 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 particularly pronounced when the medication is used in excess of the recommended dosage or for extended periods.

Patients are advised to consult a healthcare provider prior to use if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended that patients taking aspirin for cardiovascular protection seek medical advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

In summary, while ibuprofen can be effective for pain relief, it is essential for patients to be aware of these potential adverse reactions and to seek medical guidance when necessary.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

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 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, specifically those aged 60 and older, may experience an increased risk of stomach bleeding. This heightened risk necessitates careful consideration when prescribing and monitoring treatment in this population.

Additionally, the risk of heart attack or stroke may be elevated in geriatric patients who exceed the recommended dosage or duration of use. It is essential for healthcare providers to closely monitor elderly patients for any adverse effects and to ensure adherence to prescribed dosages to mitigate these risks.

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 during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

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 during the last three months of pregnancy unless specifically directed by a healthcare provider, 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, caution is recommended when considering the use of this medication in lactating mothers.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this population to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may be beneficial in guiding the management of the overdose.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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 were identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including cases of anaphylaxis, angioedema, and various skin reactions such as rash, pruritus, and urticaria. Gastrointestinal adverse events have also been reported, encompassing gastrointestinal bleeding, ulceration, and perforation.

Cardiovascular events, including myocardial infarction and stroke, have been documented. Additionally, renal adverse events such as acute renal failure and interstitial nephritis have been observed. Hepatic adverse events, including elevations in liver enzymes and instances of hepatitis, have been reported as well. Lastly, hematologic adverse events, including thrombocytopenia and aplastic anemia, have been noted in the postmarketing experience.

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 they should not use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after undergoing heart surgery.

Patients must be instructed to stop using the medication and consult a doctor if they experience 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. They should also be advised to seek medical attention if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, or if redness or swelling occurs in the painful area. Furthermore, patients should be encouraged to stop use and consult a doctor if any new symptoms arise.

When using this product, patients should be informed that taking it with food or milk may help alleviate any stomach upset. It is important to communicate that the risk of heart attack or stroke may increase if the medication is used in excess of the recommended dosage or for a duration longer than directed.

Patients should be prompted to consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. They should also be advised to seek medical advice if the stomach bleeding warning is applicable to them, or if they have a history of stomach issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should be encouraged to discuss their conditions with a healthcare provider prior to use.

Patients taking diuretics or those under a doctor's care for any serious condition should also be advised to consult a doctor or pharmacist before using this medication. Lastly, it is important to inform patients that if they are taking aspirin for heart attack or stroke, they should seek advice from a healthcare professional, as ibuprofen may diminish the benefits of aspirin.

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 temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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