Ibuprofen IBUPROFEN TRIFECTA PHARMACEUTICALS USA LLC FDA Approved Uses Temporarily relieves minor aches and pains due to Common cold headache minor pain of arthritis toothache backache muscular aches menstrual cramps temporarily reduces fever
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Substance Ibuprofen
Route
ORAL
Applications
ANDA207095
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each tablet) Ibuprofen 200mg (NSAID*) *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive Ingredients 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
Strengths
200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Common Cold Headache Minor Pain Of Arthritis Toothache Backache Muscular Aches Menstrual Cramps Temporarily Reduces Fever
Pill Appearance
Shape: round Color: brown Imprint: BI06

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0850058161037
UNII
WK2XYI10QM
Packaging

globe ibuprofin 200mg 50pk child resistant CDER

Package Descriptions
  • globe ibuprofin 200mg 50pk child resistant CDER

Overview

Uses Temporarily relieves minor aches and pains due to Common cold headache minor pain of arthritis toothache backache muscular aches menstrual cramps temporarily reduces fever

Indications & Usage

Uses Temporarily relieves minor aches and pains due to Common cold headache minor pain of arthritis toothache backache muscular aches menstrual cramps temporarily reduces fever

Dosage & Administration

Directions Do not take more than directed. The smallest effective dose should be used Adults and children 12 years and older Take 1 tablet every 4-6 hours while symptoms persist If pain or fever does not respond to 1 tablet, 2 tablets may be used Do not exceed 6 tablets in 24 hours, unless directed by a doctor Children under 12 years of age Ask a doctor

Warnings & Precautions
Warnings Allergy alert Ibuprofen may cause severe allergic reactions, especially in people allergic to aspirin. Symptoms may include hives facial swelling asthma (wheezing) shock skin reddening rash blisters 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: are age 60 or older have stomach ulcers or bleeding problems take blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed 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
Purpose

Purpose Pain Releiver / Fever Reducer nonsteroidal anti-inflammatory drug

Do Not Use

Do Not Use If you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery

When Using

When using this product Take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

Stop Use and ask a doctor if You experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better You have symptoms of heart problems or stroke chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling Pain gets worse or lasts more than 10 days Fever gets worse or lsats more than 3 days redness or swelling is present in the painful area any new symptoms appear

Keep Out of Reach of Children

Keep out of reach of children 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).

Questions

Questions or Comments? Call 1-888-296-9067 IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR COMPLETE WARNINGS AND INFORMATION.


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