Ibuprofen

Tablets · Spirit Pharmaceutical LLC

Dosage Form

Tablets

Manufacturer

Spirit Pharmaceutical LLC

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
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
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)

68210-6114-1

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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

Heart attack and stroke warning

NSAID's except aspirin increases 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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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 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 tablet every 4 to 6 hour…

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…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

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

Storage and handlingread all warnings and directions before use. Keep carton. store between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F)

Package labelCOMPARE TO ADVIL® ACTIVE INGREDIENT† Dr. Juan's Santo Remedio PARA EL DOLOR Para el Dolor / Bajar La Fiebre Anti-inflamatorio Ibuprofeno Ibuprofen Pain Reliever / Fever Reducer Anti-inflammatory (NSAID) 200 MG · 100 TABL…