Label: ASPIRIN 325MG- aspirin tablet
- NDC Code(s): 51532-0232-2
- Packager: Afassco Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated November 23, 2016
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- ACTIVE INGREDIENT
Aspirin USP (NSAID) 325 mgClose
- INDICATIONS & USAGE
For the relief of:
• headache • minor aches and pains
• for reduction of fever of colds and flu
• menstrual discomfort • toothacheClose
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.
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 directedClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.Close
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.Close
In case of overdose, get medical help or contact a Poison Control Center right away.Close
- DOSAGE & ADMINISTRATION
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.Close
- INACTIVE INGREDIENT
SEE ORIGINAL BOX FOR COMPLETE
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-0232 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength POVIDONE K30 (UNII: U725QWY32X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white (SNOW WHITE) Score no score Shape ROUND Size 10mm Flavor Imprint Code FR21 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51532-0232-2 2 in 1 PACKET; Type 0: Not a Combination Product 10/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/31/2015 Labeler - Afassco Inc. (609982723) Registrant - ULTRAtab Laboratories, Inc. (151051757) Establishment Name Address ID/FEI Business Operations Ultraseal Corporation 085752004 pack(51532-0232) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(51532-0232)