Active Ingredient (In Each Tablet)
Ibuprofen, 200mg (NSAID*)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Ibuprofen (NDC 69396-141). 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 tablet), purpose, do not use, uses, warnings, ask a doctor before use if, ask a doctor or pharmacist before use if you are, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen, 200mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain Releiver / Fever Reducer
nonsteroidal anti-inflammatory drug
Temporarily relieves minor aches and pains due to
temporarily reduces fever
Allergy alert
Ibuprofen may cause severe allergic reactions, 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 a NSAID, which may cause severe stomach bleeding. The chances are higher if you:
Heart attack or 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.
Contains FD+C Yellow No. 5 (tartrazine) as a color additive
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Adults and children 12 years and older
Children under 12 years of age
You experience any of the following signs of stomach bleeding:
You have symptoms of heart problems or stroke
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.
TAMPER EVIDENTchild resistant packets. Do not use any opened or torn packets.
Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide
Call 1-888-296-9067
IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR COMPLETE WARNINGS AND INFORMATION.
Take with food or milk if stomach upset occurs
Distributed By:
Trifecta Pharmaceuticals USA®
Ft. Lauderdale, FL. 33301 USA
1-888-296-9067
*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil®
Reorder No. 2022
Made in the USA
* Please review the disclaimer below.