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LOW DOSE ASPIRIN by CARDINAL HEALTH

Medically reviewed on March 2, 2017

Dosage form: tablet, coated
Ingredients: ASPIRIN 81mg
Labeler: CARDINAL HEALTH
NDC Code: 70000-0202

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.

Active ingredient (in each tablet) Purpose

Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . .Pain reliever

*nonsteroidal anti-inflammatory drug

anhydrous lactose,

carnauba wax, colloidal silicon dioxide,

croscarmellose sodium, D&C yellow #10

aluminum lake, iron oxide ochre, methacrylic acid

and ethyl acrylate copolymer, microcrystalline

cellulose, polysorbate 80, simethicone, sodium

hydroxide, sodium lauryl sulfate, starch, talc,

titanium dioxide, triethyl citrate

Directions

_ drink a full glass of water with each dose

_ adults and children 12 years and over: take 4 to

8 tablets every 4 hours not to exceed 48 tablets

in 24 hours unless directed by a doctor

_ children under 12 years: consult a doctor

Uses

_ temporarily relieves minor aches and pains

Because of its delayed action, this product will not

provide fast relief of headaches or other

symptoms needing immediate relief.

Warnings

Reye’s syndrome: Children and teenagers who have or

are recovering from chicken pox or flu-like symptoms

should not use this product. When using this product,

if changes in behavior with nausea and vomiting occur,

consult a doctor because these symptoms could be an

early sign of Reye's syndrome, a rare but serious

illness.

Allergy alert: Aspirin may cause a severe allergic

reaction, which may include: _ hives

_ facial swelling _ shock _ asthma (wheezing)

Stomach bleeding warning: This product contains an

NSAID, which may cause severe stomach bleeding.

The chance is higher if you: _ are age 60 or older

Pain reliever

Keep out of reach of children. In case of

overdose, get medical help or contact a Poison

Control Center (1-800-222-1222) right away.

LOW DOSE ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0202
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
D&C YELLOW NO. 10 
FERRIC OXIDE YELLOW 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
POLYSORBATE 80 
DIMETHICONE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeHEART
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0202-2120 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:70000-0202-3300 TABLET, COATED in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/06/2017
Labeler - CARDINAL HEALTH (097537435)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC037052099manufacture(70000-0202)

 
CARDINAL HEALTH

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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