Ibuprofen Tablet, Coated [Western Family Foods, Inc.] -

IBUPROFEN TABLET, COATED [WESTERN FAMILY FOODS, INC.]
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NDC	55312-219-20
Set ID	2a8d1e14-ffb6-49ad-95b0-ad3fe34bfc49
Category	HUMAN OTC DRUG LABEL
Packager	Western Family Foods, Inc.
Generic Name
Product Class
Product Number
Application Number	ANDA079174

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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

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:

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.

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

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 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

www.westernfamily.com

Manufactured by:

Granules India Limited

Madhapur, Hyderabad- 500081, INDIA
Package Labeling

Ibuprofen coated tablets 200 mg

INGREDIENTS AND APPEARANCE

IBUPROFEN
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-219
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BROWN (reddish)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G2
Contains

#	Item Code	Package Description
Packaging
1	NDC:55312-219-20	2 in 1 BOX
1		100 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079174	09/01/2011

Labeler - Western Family Foods, Inc. (192166072)