Ibuprofen IBUPROFEN BREEDEN BROTHERS, LLC FDA Approved Uses 26 words 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
Generic: IBUPROFEN
Mfr: BREEDEN BROTHERS, LLC FDA #25 OTC
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
ANDA075010
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each brown tablet) Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients carnauba wax colloidal silicon dioxide corn starch hypromellose lactose 29 words anhydrous magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol red iron oxide sodium starch glycolate stearic acid titanium dioxide
Strengths
200 mg
Quantities
100 tablets
Treats Conditions
Uses 26 Words 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
All Product Codes
UNII
WK2XYI10QM
Packaging

PRINCIPAL DISPLAY PANEL NDC 70729-291-12 b + b IBUPROFEN Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID) 100 Tablets PRINCIPAL DISPLAY PANEL NDC 70729-291-12 b + b IBUPROFEN Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID) 100 Tablets PRINCIPAL DISPLAY PANEL NDC 70729-291-12 b + b IBUPROFEN Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID) 100 Tablets

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 70729-291-12 b + b IBUPROFEN Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID) 100 Tablets PRINCIPAL DISPLAY PANEL NDC 70729-291-12 b + b IBUPROFEN Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID) 100 Tablets PRINCIPAL DISPLAY PANEL NDC 70729-291-12 b + b IBUPROFEN Ibuprofen Tablets USP, 200 mg Pain Reliever/ Fever Reducer (NSAID) 100 Tablets

Overview

Uses 26 words 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 26 words 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 67 words 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 children under 12 years: ask a doctor

Warnings & Precautions
Warnings 53 words See carton for complete warnings (short label only) See vial card for complete warnings (vial label only) 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 74 words 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, 37 words and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use 24 words • 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 57 words • 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 37 words • 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 13 words • take with food or milk if stomach upset occurs Stop use and ask a doctor if 89 words 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not 70 words 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Purpose

Purpose Pain reliever/fever reducer

Do Not Use

Do not use 24 words • 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 13 words • take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

Stop use and ask a doctor if 89 words 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 (1-800-222-1222) right away.

Questions

Questions or comments? 12 words Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday (or specific to customer’s labeling guide) Additional Information: • Change to version 44-291.09 BBW1116 • In Legend Box update DF version to 44-291.09


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