ASPIRIN ENTERIC COATED- aspirin tablet, coated 
Unit Dose Services

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 ENTERIC COATED

HOW SUPPLIED

Product: 50436-0127

NDC: 50436-0127-1 30 TABLET, COATED in a BOTTLE

ASPIR LOW (ASPIRIN) TABLET

Label Image
ASPIRIN ENTERIC COATED 
aspirin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-0127(NDC:49483-481)
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
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
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code HEART
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50436-0127-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/19/2015
Labeler - Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Business Operations
Unit Dose Services 831995316 REPACK(50436-0127) , RELABEL(50436-0127)

Revised: 8/2017
Document Id: b6664165-7beb-407d-97a4-72ce8daba334
Set id: 8ebcbc13-0323-454a-9834-b6ea326d4e46
Version: 6
Effective Time: 20170804
 
Unit Dose Services