VALUE PHARMA ASPIRIN PAIN RELIEVER- aspirin tablet

Value Pharma by

Drug Labeling and Warnings

Value Pharma by is a Otc medication manufactured, distributed, or labeled by Ajes Pharmaceuticals,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ASPIRIN

PURPOSE

Purpose

Pain Reliever

INACTIVE INGREDIENT

Inactive Ingredients

KEEP OUT OF REACH OF CHILDREN

In case of over dose get medical help and contact a Poison Control Center immediately.

INDICATIONS & USAGE

For temporary relief of minor aches and pains or as recommended by your Doctor. Because of this products delayed release action, this product will not provide fast relief of headaches or symptoms needing immediate relief.

WARNINGS

Do not use if you have ever had an allergic reaction to any other pain relievers/fever reducers. Children or teenagers who are recovering from the Chicken Pox or flu like symptoms should not use this product. When using this product if changes in behavior occur with nausea and vomiting occur,consult a Doctor because this could be a sign of Reye's Syndrome, a rare
 but serious illness.

DOSAGE & ADMINISTRATION

Directions - drink a full glass of water with each dose. Adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed48 tablets in 24 hours unless directed by a doctor. Children under 12 years: consult a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VALUE PHARMA   ASPIRIN PAIN RELIEVER
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42787-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg  in 81 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	yellow (Yellow color)	Score	no score
Shape	ROUND (Round Pill)	Size	6mm
Flavor		Imprint Code	C3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42787-101-12	1 in 1 CARTON	10/01/2012
1		81000 mg in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	10/01/2012

Labeler - Ajes Pharmaceuticals,LLC (159945393)

Establishment
Name	Address	ID/FEI	Business Operations
Ajes Pharmaceuticals,LLC		159945393	manufacture(42787-101)