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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50332-0118
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0118-450 in 1 BOX, UNIT-DOSE
12 in 1 PACKET
2NDC:50332-0118-7125 in 1 BOX, UNIT-DOSE
22 in 1 PACKET
3NDC:50332-0118-8250 in 1 BOX, UNIT-DOSE
32 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/03/1987
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