IBUPROFEN IBUPROFEN LIL' DRUG STORE PRODUCTS, INC. FDA Approved USES temporarily relieves minor aches and pains 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
ANDA075010

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT (IN EACH TABLET) Ibuprofen 200 mg (NSAID 1 nonsteroidal anti-inflammatory drug )
Inactive Ingredients
INACTIVE INGREDIENTS carnauba wax colloidal silicon dioxide corn starch hypromellose lactose anhydrous magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol red iron oxide sodium starch glycolate stearic acid titanium dioxide
Strengths
200 mg
Quantities
2 tablets
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Toothache Backache Menstrual Cramps The Common Cold Muscular Aches Minor Pain Of Arthritis Temporarily Reduces Fever
Pill Appearance
Shape: round Color: brown Imprint: 44;291

Identifiers & Packaging

Container Type UNKNOWN
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL COMPARE TO THE ACTIVE INGREDIENTS IN Advil* Ibuprofen Pain Reliever / Fever Reducer (NSAID) , 200mg 2 TABLETS PER POUCH IBUPROFEN

Package Descriptions
  • PRINCIPAL DISPLAY PANEL COMPARE TO THE ACTIVE INGREDIENTS IN Advil* Ibuprofen Pain Reliever / Fever Reducer (NSAID) , 200mg 2 TABLETS PER POUCH IBUPROFEN

Overview

USES temporarily relieves minor aches and pains 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 pains 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 adults and children 12 years and over: 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 store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

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. 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 before use if the stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs 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 the 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen 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 Center right away (1-800-222-1222).
Purpose

PURPOSE Pain reliever/Fever reducer

Do Not Use

Do not use if you have ever had an allergic reaction 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

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 the 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. 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°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Questions

QUESTIONS OR COMMENTS? call toll-free 1-877-507-6516 (M-F 8 AM-4:30PM CST)


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