IBUTAB- ibuprofen tablet

Ibutab by

Drug Labeling and Warnings

Ibutab by is a Otc medication manufactured, distributed, or labeled by Zee Medical Inc, Ultra Seal Corporation , Ultra Seal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose-Pain Reliever/Fever Reducer

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

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

PREGNANCY OR BREAST FEEDING

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

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 INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUTAB 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35418-750
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	brown (chocolate brown)	Score	no score
Shape	ROUND (IBU;200)	Size	110mm
Flavor		Imprint Code	IBU;200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35418-750-69	500 in 1 CARTON	06/12/2012
1	NDC: 35418-750-67	125 in 1 CARTON
1	NDC: 35418-750-68	50 in 1 CARTON
1	NDC: 35418-750-02	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079129	06/12/2012

Labeler - Zee Medical Inc (009645623)

Registrant - Ultra Seal Corporation (085752004)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(35418-750)