Drug Labeling and Warnings

Drug Details

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LOW DOSE ASPIRIN- aspirin tablet, coated 
TIME CAP LABORATORIES, INC

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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LABEL
LOW DOSE ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49483-481
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint Code HEART
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49483-481-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 49483-481-12120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC: 49483-481-001000000 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/19/2015
Labeler - TIME CAP LABORATORIES, INC (037052099)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(49483-481)

Revised: 6/2015
 
TIME CAP LABORATORIES, INC


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