ASPIRIN- aspirin tablet, chewable 
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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ASPIRIN 81mg

Active Ingredient

(in each tablet)

Aspirin 81 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Use

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

Other Information

Inactive Ingredients

corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC: 17714-009-36 – 36 COUNT

ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ORANGE (UNII: 5EVU04N5QU)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColororangeScorescore with uneven pieces
ShapeROUNDSize8mm
FlavorORANGEImprint Code AP;009
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17714-009-3636 in 1 BOTTLE04/15/1988
11 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/15/1988
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(17714-009)

Revised: 12/2019
Document Id: 999a5403-4945-d811-e053-2995a90a42dc
Set id: f6a9ea44-08b8-4a33-bfbd-68cb2d852c39
Version: 3
Effective Time: 20191213
 
Advance Pharmaceutical Inc.