ASPIRIN- aspirin tablet 
Advance Pharmaceutical 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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ENTERIC COATED ASPIRIN 81mg

Active Ingredient

(in each tablet)

Aspirin 81 mg (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 behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

Other Information

Inactive Ingredients

croscarmellose sodium, D&C Yellow #10 (Al-Lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

Questions or Comments

Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Safer for your stomach than pain or Buffered Aspirin

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

184d7697-figure-01
184d7697-figure-02
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NDC: 17714-121-12 – 120 Tablets

NDC: 17714-121-06  - 240 Tablets

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code AP;121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17714-121-12120 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2013
2NDC:17714-121-06240 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2013
3NDC:17714-121-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34306/12/1999
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(17714-121)

Revised: 10/2017
Document Id: 5cc8bd8c-1d8c-180b-e053-2a91aa0ac490
Set id: 8977b821-2843-4436-bd3b-bb902a4b787e
Version: 3
Effective Time: 20171030
 
Advance Pharmaceutical Inc.