Ibuprofen Immediate Release IBUPROFEN STRIDES PHARMA INC FDA Approved Uses 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
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Substance Ibuprofen
Route
ORAL
Applications
ANDA091355

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each Orange caplet ** ) Ibuprofen 200 mg (NSAID) * * nonsteroidal anti-inflammatory drug **capsule-shaped tablets
Inactive Ingredients
Inactive Ingredients colloidal silicon dioxide corn starch D&C yellow no.10 aluminum lake hypromellose magnesium stearate microcrystalline cellulose pregelatinized starch sodium starch glycolate talc titanium dioxide and triacetin
Strengths
200 mg
Treats Conditions
Uses 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: round Color: white Imprint: IBU200

Identifiers & Packaging

Container Type UNKNOWN
UNII
WK2XYI10QM
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label blank label

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label blank label

Overview

Uses 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

Uses 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

Not available

Warnings & Precautions
WARNINGS Allergy alert: Ibuprofen 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 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 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.
Boxed Warning
Important: Read all product information before using. Keep the box for important information.
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

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 lasts 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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Storage & Handling

Other Information store between 20-25 0 C (68-77 0 F) do not use if carton is opened. Do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing

Questions

Questions or Comments Call 1-877-244-9825 (toll-free)


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