Ibuprofen

Safetec of America, Inc.

Dosage Form

N/A

Manufacturer

Safetec of America, Inc.

Active ingredient

Ibuprofen200 mg

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

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

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

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

61010-4411-0
61010-4411-1
61010-4411-2

Full prescribing information (for healthcare professionals)

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Drug Facts

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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.

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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

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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

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adults and children 12 years and older	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

Active ingredient

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.do not lake more than directed the smallest effective dose should be used adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 ta…

Do not use if…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)

Ask a doctor before use 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 pain gets worse or lasts more than 10 days fever gets worse or…

Ask a doctor or pharmacist before use if…taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug

Stop use and talk to a doctor if…if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery

Package labelSafetec of America, Inc. DO NOT USE IF POUCH IS TORN OR DAMAGED Manufactured for Safetec of America, Inc.Buffalo NY 14215 Ibuprofen Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* GLUTEN-FREE 2 Coated Tablets

Package labelSafetec® of America, Inc. *Compare to the active ingredient in Advil® NDC 61010-4411-1 Ibuprofen Ibuprofen Tablets USP, 200 mg PUSH TO OPEN Dispense through opening Pain Reliever/Fever Reducer (NSAID)* Relieves minor ach…

Package labelSafetec® of America, Inc. *Compare to the active ingredient in Advil® NDC 61010-4411-2 Ibuprofen Ibuprofen Tablets USP, 200 mg - Pain Reliever/Fever Reducer (NSAID)* GLUTEN-FREE Relieves minor aches and pains Fever reduc…

What it looks like

Package codes (NDC)

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