FDA Label for Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABELING
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Western Family Foods, Inc.. 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 (In Each Tablet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain Releiver/ 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
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
- are age 60 or oder
- have had stomach ulders or bleeding problems
- take blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks everyday while using this prdouct
- take more or for a longer time than directed.
If an allergic reaction occurs, stop use an 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:
Do Not Use
- if you 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
- 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 are taking a diuretic.
Ask A Doctor Or Pharmacist Before Use If You Are
- 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.
When Using This Product
- 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.
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 stoolos
- have stomach pain that does not bet better
- Pain gets worse or last more than 10 days
- Fever gets worse or last more than 3 days
- Redness or swelling is presentin 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 druing the last 3 months of pegnancy unless defintely 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
- 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
- ask a doctor
Adults and children 12 years and older | |||
children under 12 years |
:
Other Information
- store between 20o- 25o C (68o- 77o F)
- read all warnings and directions before use. Keep carton
- do not use if imprinted foil under cap is broken or missing
- †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil®
Inactive Ingredients
colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin
Questions Or Comments?
Call toll free 1-503-639-6300 Monday- Friday 9AM- 5PM PST
Principal Display Panel
Ibuprofen Coated Tablets 200 mg each
Pain Reliever/ Fever Reducer (NSAID)*
Compare to the active ingredient in ADVIL®†
SEE NEW WARNINGS INFORMATION
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Proudly distributed by
Western Family Foods, Inc.
P.O Box 4057, Portland, OR 97208 U.S.A
Manufactured by:
Granules India Limited
Madhapur, Hyderabad- 500081, INDIA
Package Labeling
Ibuprofen coated tablets 200 mg
* Please review the disclaimer below.