IBUPROFEN- ibuprofen tablet 
HART Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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IBUPROFEN

Active Ingredient (in each tablet): Ibuprofen (NSAID)* 200mg (*nonsteroidal anti-inflammatory drug)

Purpose: Pain Reliever / Fever Reducer

Uses: Temporarily relieves minor aches and pains due to

Temporarily reduces fever

Warnings:

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:

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, 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. 1-800-222-1222

Directions: Do not take more than directed; the smallest effective dose should be used.

Adults and children 12 years of age and over:

Children under 12 years of age: ask a doctor

Inactive Ingredients: Carnauba Wax, Croscarmellose Sodium, FD&C Blue #2 Lake, FD&C Red #40 Lake, FD&C Yellow #6 Lake, D&C Yellow #10 Lake, Hydroxypropyl Methylcellulose, Magnesiuum Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Red Iron Oxide, Silicon Dioxide, Titanium Dioxide

Ibuprofen.jpg

IBUPROFEN 
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0118
Route of Administration ORAL DEA Schedule     
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)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color brown Score no score
Shape ROUND Size 10mm
Flavor Imprint Code IBU200
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50332-0118-4 50 in 1 BOX, UNIT-DOSE
1 2 in 1 PACKET
2 NDC:50332-0118-7 125 in 1 BOX, UNIT-DOSE
2 2 in 1 PACKET
3 NDC:50332-0118-8 250 in 1 BOX, UNIT-DOSE
3 2 in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/03/1987
Labeler - HART Health (069560969)

Revised: 11/2012
Document Id: c390ecb3-4a05-452e-9a46-7852100ccffb
Set id: d4e98a65-dec2-40fb-a1d9-758dabc2d6d9
Version: 1
Effective Time: 20121111
 
HART Health