Active Ingredient (In Each Caplet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Pld Acquisitions Llc Dba Av�ma Pharma Solutions for the product Ibuprofen (NDC 63548-0185). 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 (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/ fever reducer
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use an seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
carnauba wax, croscarmellose sodium, FD&C yellow #6 aluminium lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Ibuprofen Tablets USP, 200 mg
Pain Reliever/ Fever Reducer (NSAID)
Coated Caplets**
**(Capsule-Shaped Tablets)
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING
Manufactured by: Avema Pharma Solutions
10400 NW 29th Terrace
Miami, FL 33172
* Please review the disclaimer below.