ASPIRIN- aspirin 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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Aspirin (NSAID)* 325mg (*non-steroidal anti-inflammatory drug)

Uses:

Temporarily relieves minor aches and pains due to:

Temporarily reduces fever

Warnings:

Reye's Syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin

Allergy altert: Aspirin may cause a several allergic reaction which may include:

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

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if:

Ask a doctor or pharmacist before use if you:

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 aspirin 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.

Adults and children 12 years of age and over:

Children under 12 years of age: ask a doctor

Inactive Ingredients: Corn Starch, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide

Aspirin.jpg

ASPIRIN 
aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0102
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code TCL011
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50332-0102-4 50 in 1 BOX, UNIT-DOSE
1 2 in 1 PACKET
2 NDC:50332-0102-7 125 in 1 BOX, UNIT-DOSE
2 2 in 1 PACKET
3 NDC:50332-0102-8 250 in 1 BOX, UNIT-DOSE
3 2 in 1 PACKET
4 NDC:50332-0102-1 500 in 1 BOX, UNIT-DOSE
4 2 in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 06/04/1986
Labeler - HART Health (069560969)

Revised: 10/2012
Document Id: bc2b8b1e-0402-4d4c-ad0f-edeafeb8f44c
Set id: bceb9d51-49b4-4a66-a67d-e2cc4f302d25
Version: 1
Effective Time: 20121028
 
HART Health