Assured Ibuprofen IBUPROFEN SPIRIT PHARMACEUTICALS LLC FDA Approved Uses temporarily relieves minor aches and pain due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
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Substance Ibuprofen
Route
ORAL
Applications
ANDA202312
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide FD&C yellow no. 6 maize starch polyethylene glycol polyvinyl alcohol povidone k30 pregelatinized starch sodium starch glycolate stearic acid talc titanium dioxide.
Strengths
200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pain Due To Headache Toothache Backache Menstrual Cramps The Common Cold Muscular Aches Minor Pain Of Arthritis Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: orange Imprint: G2

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0850026889123
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL Ibuprofen Ibuprofen Tablets 200 mg - Pain reliever/fever reducer (NSAID) Label Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Ibuprofen Ibuprofen Tablets 200 mg - Pain reliever/fever reducer (NSAID) Label Carton

Overview

Uses temporarily relieves minor aches and pain due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pain due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever

Dosage & Administration

Directions ¬ do not take more than directed ¬ the smallest effective dose should be used ¬ do not take longer than 10 days, unless directed by a doctor (see Warnings) ¬ adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist ¬ if pain or fever does not respond to 1 caplet, 2 caplets may be used ¬ do not exceed 6 caplets in 24 hours, unless directed by a doctor ¬ children under 12 years: ask a doctor

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 a nonsteroidal anti-inflammatory drug (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
Purpose

Purpose Pain reliever/fever reducer

Do Not Use

Do not use if you have ever had an allergic reaction to ibuprofen or to 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 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 ¬ leg swelling ¬ slurred speech ¬ weakness in one part or side of body ¬ 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)

Questions

Questions or comments? 1-888-333-9792


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