Your browser does not support JavaScript! IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]
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IBUTAB (ibuprofen) tablet
[Zee Medical Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active Ingredient/Tablet Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purpose-Pain Reliever/Fever Reducer

Uses
■ temporarily relieves minor aches and pains due to:
■ headache ■ the common cold ■ muscular aches
■ backache ■ toothache ■ minor pain of arthritis
■ menstrual cramps
■ temporarily reduces fever

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 (see
Warnings)
■ adults: 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
■ children under 12 years: ask a doctor

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
■ rash ■ skin reddening ■ 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
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
■ stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have problems or serious side effects from taking pain
relievers or fever reducers
■ you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, or asthma
■ you are taking a diuretic
Ask a doctor or pharmacist before use if you are
■ under a doctor's care for any serious condition
■ taking aspirin to prevent heart attack or stroke, because
ibuprofen may decrease this benefit of aspirin
■ 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 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.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

Inactive ingredients carnauba wax*, cellulose,
croscarmellose sodium*, DC yellow 10*, FDC blue 2*, FDC
red 40*, FDC yellow 6*, hydroxypropyl methylcellulose,
magnesium stearate, maltodextrin*, polyethylene glycol*,
polysorbate 80*, red iron oxide, silicon dioxide, sodium starch
glycolate*, starch*, talc*, titanium dioxide, triacetin*
*Contains one or more of these ingredients.

Mm1Ibutab, 250 Box

IBUTAB 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:35418-750
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
POLYETHYLENE GLYCOL 300 
POLYSORBATE 80 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
Colorbrown (chocolate brown) Scoreno score
ShapeROUND (IBU;200) Size110mm
FlavorImprint Code IBU;200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35418-750-69500 in 1 CARTON
1NDC:35418-750-67125 in 1 CARTON
1NDC:35418-750-6850 in 1 CARTON
1NDC:35418-750-022 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912906/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004repack(35418-750)

Revised: 6/2012
 
Zee Medical Inc

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