LOW DOSE ASPIRIN CHEWABLE- aspirin tablet, chewable 
Healthlife of USA

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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LOW DOSE ASPIRIN CHEWABLE

Drug Facts

Active Ingredient (in each Tablet)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Uses

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:

Stomach bleeding warning

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

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 

Other information

Inactive Ingredients

Principal Display Panel

Low Dose

ASPIRIN 81mg

30 Chewable Tablets 

image description

LOW DOSE ASPIRIN CHEWABLE 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-136
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DEXTRATES (UNII: G263MI44RU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
ORANGE (UNII: 5EVU04N5QU)  
STARCH, CORN (UNII: O8232NY3SJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint Code TCL;334
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69517-136-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2017
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/FEIBusiness Operations
Time-Cap Labs, Inc.037052099manufacture(69517-136)

Revised: 10/2017
Document Id: 62030708-06a6-425b-a736-a458821cb145
Set id: cd727543-10ec-4991-8036-d4668187230b
Version: 1
Effective Time: 20171009
 
Healthlife of USA