VALUE PHARMAPAIN RELIEVER EXTRA STRENGTH- aspirin tablet

Value PharmaPain Reliever by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

nonsteroidal antiinflammatory drug

INACTIVE INGREDIENT

Inactive Ingredients Hydroxypropylmethyl cellulose, polyethylene glycol, starch, talc, titanium dioxide

PURPOSE

Purpose

Pain reliever /  Fever reducer

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

INDICATIONS & USAGE

Uses provides temporary relief of: headache pain and fever of colds - muscle pain - toothache - minor pain of arthritis

WARNINGS

Warnings

Do not use - if you have ever had an allergic reaction to any other pain relievers/fever reducers.

Reyes Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a  sever allergic  reaction which may include : facial swelling - asthma (wheezing) - shock - hives

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chances are higher if you are- 60 years of age or older - have had stomach ulcer bleeding problems - take a blood thinner (anticoagulant) or steroid drug - take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, others) - have 3 or more alcoholic drinks everyday while using this product - take more or for a longer time than directed

DOSAGE & ADMINISTRATION

Directions - drink a full glass of water with each dose - Adults and children 12 years of age and over: take 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours. Children under 12: consult a doctor

NURSING MOTHERS

If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn or complications during delivery

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VALUE PHARMAPAIN RELIEVER  EXTRA STRENGTH
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42787-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E)	Aspirin	325 mg  in 325 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
talc (UNII: 7SEV7J4R1U)
Titanium Dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white color)	Score	no score
Shape	ROUND (Round Tablet)	Size	11mm
Flavor		Imprint Code	C10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42787-102-50	1 in 1 CARTON
1		16250 mg in 1 BOTTLE

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(42787-102) , relabel(42787-102) , repack(42787-102)