Otc - Active Ingredient
(in each capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
* nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Amneal Pharmaceuticals Llc for the product Ibuprofen (NDC 65162-356). 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 otc - active ingredient, otc - purpose, indications and usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
* nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducer
Uses
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 and 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
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, 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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
FD&C Blue # 1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol
Call 1-877-835-5472
Monday through Friday 9AM - 5PM EST.
Read and keep carton for complete warnings and information.
Do not use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®
Rev. 11-2017-01
* Please review the disclaimer below.