Active Ingredient
Ibuprofen 200 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Inc. for the product Ibuprofen (NDC 12634-860). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, do not use, ask doctor, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 200 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
USESAllergy alert:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:
Ask a doctor before use if you have
Ask a doctor before use if you are
- ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
| Adults and children 12 years and older |
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| Children under 12 years |
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Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Corn Starch, Titanium Dioxide.
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Distributed by:
RejuviLife, Phoenix, AZ
RejuviLife is a trademark of Apotheca Inc.
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