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Name:Ibuprofen
Manufacturer:Remedyrepack Inc.
Category:Prescription Marketed Drugs


IBUPROFEN  - ibuprofen tablet 
REMEDYREPACK INC.

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OTC - ACTIVE INGREDIENT

(in each brown tablet)
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE

Pain reliever/fever reducer

OTC - WHEN USING

     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

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 and 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 older
     have had stomach ulcers or bleeding problems
     take a blood thinning (anticoagulant) or steroid drug
     take other drugs containing perscription or nonperscription 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

OTC - DO NOT USE

     if you have ever had an allergic reaction to any other pain reliever/fever reducer
     right before or after heart surgery

OTC - ASK DOCTOR

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

OTC - ASK DOCTOR/PHARMACIST

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

OTC - WHEN USING

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 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.

DIRECTIONS

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 (seeWARNINGS) adults and children 12 years and over: 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 at controlled room temperature
     avoid excessive heat above 40(104
     use by expiration date on package

INACTIVE INGREDIENT

carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: IBUPROFEN
GENERIC: IBUPROFEN
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-123-02
STRENGTH:200 mg
COLOR: orange
SHAPE: ROUND
SCORE: No score
SIZE: 13 mm
IMPRINT: IP;143
QTY: 30
MM1



MM2



IBUPROFEN 
ibuprofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-123(NDC:16103-0395-99)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
STARCH, CORN  
HYPROMELLOSES  
LACTOSE  
MAGNESIUM STEARATE  
POLYDEXTROSE  
POLYETHYLENE GLYCOL  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color orange Score no score
Shape ROUND (TABLET) Size 13mm
Flavor Imprint Code IP;143
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49349-123-02 30 TABLET ( TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075659 12/08/2010

Labeler - REMEDYREPACK INC. (829572556)

Revised: 12/2010 REMEDYREPACK INC.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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