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  5. Label Information: Ibuprofen Pain Reliever/ Fever Reducer

FDA Label for Ibuprofen Pain Reliever/ Fever Reducer

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. ALLERGY ALERT
    5. STOMACH BLEEDING WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING
    12. KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?

Ibuprofen Pain Reliever/ Fever Reducer Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Ibuprofen USP, 200mg (NSAID)**
**nonsteroidal anti-inflammatory drug


Purpose



Pain reliever/fever reducer


Uses



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


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 chances are 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


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



■ you have problems or serious side effects from taking pain relievers or fever reducers ■ the stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you
have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you have asthma ■ you are taking a diuretic


Ask A Doctor Or Pharmacist Before Use If You Are



■ taking aspirin to prevent 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


When Using This Product



take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed


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 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 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 right away (1-800-222-1222).


Directions



■ do not take 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 tablets may be used ■ do not exceed 6 tablets in 24 hours unless directed by a doctor
Children under 12 years: ask a doctor


Other Information



store between 20-25 °C (68-77° F). ■ Read all warnings and directions before use Do not use if
seal under bottle cap is broken or missing.


Inactive Ingredients



Colloidal silicon dioxide, corn starch, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin


Questions Or Comments?



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