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Aspirin 325mg

Medically reviewed on November 23, 2016.

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: Afassco Inc.
NDC Code: 51532-0232

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.

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

ASPIRIN 325MG 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-0232
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 
MICROCRYSTALLINE CELLULOSE 
STARCH, CORN 
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeFR21
Contains    
Packaging
#Item CodePackage Description
1NDC:51532-0232-22 TABLET in 1 PACKET
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/FEIOperations
Ultraseal Corporation085752004pack(51532-0232)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture(51532-0232)

 
Afassco Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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