Ibuprofen Immediate Release IBUPROFEN STRIDES PHARMA INC. FDA Approved USE(S) temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT(S ) (ineach orange tablet or caplet ** ) Ibuprofen USP 200 mg (NSAID) * * nonsteroidal anti-inflammatory drug ** capsule-shaped tablets
Inactive Ingredients
INACTIVE INGREDIENTS (S) colloidal silicon dioxide corn starch hypromellose magnesium stearate microcrystalline cellulose pregelatinized starch red iron oxide sodium starch glycolate talc titanium dioxide and triacetin QUESTIONS OR COMMENTS? Call 1-855-742-7868 (toll-free): weekdays 8.00 AM to 8.00 PM EST Manufactured by: Strides Shasun Limited Puducherry - 605 014 India. PON/DRUGS/16134193 Distributed by: Strides Pharma Inc. East Brunswick NJ 08816 May 2017
Strengths
200 mg
Treats Conditions
Use S Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Minor Pain Of Arthritis Toothache Backache The Common Cold Menstrual Cramps Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: orange Imprint: IBU200

Identifiers & Packaging

Container Type BOTTLE
UPC
0359556855412
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL Package Label (Caplet Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets See New Warnings NDC 59556-856-41 Ibuprofen Tablets, USP 200 mg Pain Reliever/Fever Reducer (NSAID)* 24 Coated Caplets** **capsule-shaped tablets *nonsteroidal anti-inflammatory drug Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets See New Warnings NDC 59556-855-41 Ibuprofen Tablets, USP 200 mg Pain Reliever/Fever Reducer (NSAID)* 24 Coated Tablets *nonsteroidal anti-inflammatory drug ibu-24-cap-car ibu-24-cap-cont ibu-24-tab-car ibu-24-tab-cont

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Package Label (Caplet Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets See New Warnings NDC 59556-856-41 Ibuprofen Tablets, USP 200 mg Pain Reliever/Fever Reducer (NSAID)* 24 Coated Caplets** **capsule-shaped tablets *nonsteroidal anti-inflammatory drug Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets See New Warnings NDC 59556-855-41 Ibuprofen Tablets, USP 200 mg Pain Reliever/Fever Reducer (NSAID)* 24 Coated Tablets *nonsteroidal anti-inflammatory drug ibu-24-cap-car ibu-24-cap-cont ibu-24-tab-car ibu-24-tab-cont

Overview

USE(S) temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Indications & Usage

USE(S) temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold 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 or caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used do not exceed 6 tablets or caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor OTHER INFORMATION store between 20°-25°C (68° - 77°F) do not use if imprinted text "SEALED FOR YOUR PROTECTION" on the safety seal under cap is broken or missing Sodium free Each tablet contains 0.714 mg of Magnesium see end panel for lot number and expiration date.

Warnings & Precautions
WARNINGS Allergy alert: Ibuprofen USP may cause a severe allergic reaction, 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or non prescription 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 and stroke warning: NSAIDs, except aspirin, increase the risk of heart failure, and stroke. these can be fatal. The risk is higher if you use more than directed or for longer than directed.
Purpose

PURPOSE Pain reliever/fever reducer

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 the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use & Ask a Doctor

STOP USE AND ASK 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 in 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 lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health care professional before use. it is especially important not to use ibuprofen USP 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

KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a poison control centre (1-800-222-1222) right away.


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