IBUPROFEN IBUPROFEN ADVANCED FIRST AID, INC. FDA Approved Uses: temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • toothache • menstrual cramps • common cold • temporarily reduces fever
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Substance Ibuprofen
Route
ORAL
Applications
ANDA079174

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)
Inactive Ingredients
Inactive Ingredients: crosscarmellose sodium* FD& C Blue #2* FD& C red #40* FD& C Yellow #6* hypromellose* iron oxide red* lactose monohydrate* magnesium stearate* maltodextrin* medium chain triglycerides* microcrystalline cellulose* polydextrose* polyethylene glycol* polyvinyl alcohol* povidone (K-30)* silicon dioxide sodium starch glycolate* starch stearic acid* talc* titanium dioxide triacetin* *contains one or more of these ingredients
Strengths
200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Backache Minor Pain Of Arthritis Toothache Menstrual Cramps Common Cold Temporarily Reduces Fever

Identifiers & Packaging

Container Type UNKNOWN
UNII
WK2XYI10QM
Packaging

ADVANCED IBUPROFEN

Package Descriptions
  • ADVANCED IBUPROFEN

Overview

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

Indications & Usage

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

Dosage & Administration

Directions: Adults and children 12 years of age and older: • do not take more than directed • the smallest effective dose should be used • take 1 tablet every 4 to 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: do not use for children under 12 years of age unless directed by 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 • 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 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 an NSAID [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. Do not use: • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor use if you have: • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain • ulcers • bleeding problems • high blood pressure • heart disease, liver cirrhosis, or kidney disease • taken a diuretic • reached age 60 or older Ask a doctor or pharmacist before use if you are: • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • under a doctor’s care for any serious condition • taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin When using this product: • take with food or milk if stomach upset occurs • long term continuous use may increase the risk of heart attack or stroke Stop use and ask a doctor if: • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear
Purpose

pain reliever/fever reducer

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.


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