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Low Dose Aspirin Chewable

Dosage form: tablet, chewable
Ingredients: ASPIRIN 81mg
Labeler: Healthlife of USA
NDC Code: 69517-136

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.

LOW DOSE ASPIRIN CHEWABLE

Drug Facts

Active Ingredient (in each Tablet)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Uses
  • temporarily relieves minor aches and pains
  • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

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 behaviour 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:

  • facial swelling
  • hives
  • 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
  • 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

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

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

Other information
  • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING
  • store at 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredients
  • Butylated Hydroxytoluene
  • Dextrates
  • FD&C Yellow No.6
  • Cellulose, Microcrystalline
  • Corn Starch
  • Orange
  • Modified corn starch
  • Saccharin soidum 
  • Stearic acid 

Principal Display Panel

Low Dose

ASPIRIN 81mg

30 Chewable Tablets 

LOW DOSE ASPIRIN CHEWABLE 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-136
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
DEXTRATES 
FD&C YELLOW NO. 6 
CELLULOSE, MICROCRYSTALLINE 
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) 
ORANGE 
STARCH, CORN 
SACCHARIN SODIUM 
STEARIC ACID 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeTCL;334
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-136-3030 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/09/2017
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Time-Cap Labs, Inc.037052099manufacture(69517-136)

Revised: 10/2017
 
Healthlife of USA

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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