ASPIRIN CHEWABLE- aspirin 81 mg tablet 
Safecor Health, LLC

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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Active Ingredient (in each tablet)

Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

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 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

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if

you are taking a prescription drug for

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

It is especially important not to use aspirin during the last three (3) months of pregnancy unless specifically 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 childen.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information:

Inactive ingredients:

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium.

Principal Display Panel

Aspirin

81 mg

Chewable Tablet

Mfg: Allegiant Health

Lot:22A0131 Exp:09/06/24

PKG BY: Safecor Health

Woburn, MA

image description
ASPIRIN  CHEWABLE
aspirin 81 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-129(NDC:69168-288)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DEXTRATES (UNII: G263MI44RU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize7mm
FlavorORANGEImprint Code AZ013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48433-129-01100 in 1 BOX11/01/2022
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2022
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC078805287repack(48433-129) , relabel(48433-129)

Revised: 12/2022
Document Id: 1421e480-ad49-41c1-86d8-cc6b2be39e23
Set id: b499f378-db7c-464e-bee3-eb23f8fdaced
Version: 1
Effective Time: 20221228
 
Safecor Health, LLC