ASPIRIN 325MG- aspirin tablet 
Afassco 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 USP (NSAID) 325 mg

Pain Reliever

Uses:

For the relief of:

• headache • minor aches and pains

• for reduction of fever of colds and flu

• menstrual discomfort • toothache

Warnings:

Reye’s Syndrome:

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s Syndrome, a rare but serious illness reported to be associated with aspirin.

Stomach Bleeding:

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.The chance is higher if you: have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • have 3 or more alcoholic drinks every day while using this product • take with other drugs containing an NSAID • take more or for a longer time than directed

Keep out of reach of children.

If pregnant or breast-feeding, ask a health professional before use.

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

Directions:

Do not use more than directed.

Adults and children 12 years of age and older: 1 to 2 tablets every 4 hours, do not exceed 12 tablets in 24 hours.

Children under 12 consult a physician.

SEE ORIGINAL BOX FOR COMPLETE

PRODUCT INFORMATION

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ASPIRIN 325MG 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-0232
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code FR21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51532-0232-22 in 1 PACKET; Type 0: Not a Combination Product10/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/31/2015
Labeler - Afassco Inc. (609982723)
Registrant - ULTRAtab Laboratories, Inc. (151051757)
Establishment
NameAddressID/FEIBusiness Operations
Ultraseal Corporation085752004pack(51532-0232)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(51532-0232)

Revised: 9/2019
Document Id: dd718190-9753-4ac4-b7e0-63fdc1965e07
Set id: 73e74c1c-a556-4d2b-a15e-fd2786ea057d
Version: 6
Effective Time: 20190921
 
Afassco Inc.