ASPIRIN 325MG- aspirin tablet

Aspirin 325mg by

Drug Labeling and Warnings

Aspirin 325mg by is a Otc medication manufactured, distributed, or labeled by Afassco Inc., ULTRAtab Laboratories, Inc., Ultraseal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Aspirin USP (NSAID) 325 mg

PURPOSE

Pain Reliever

INDICATIONS & USAGE

Uses:

For the relief of:

headache minor aches and pains

for reduction of fever of colds and flu

menstrual discomfort toothache

WARNINGS

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

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

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

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

SEE ORIGINAL BOX FOR COMPLETE

PRODUCT INFORMATION

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ASPIRIN 325MG 
aspirin tablet

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)