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Value PharmaPain Reliever Extra Strength

Medically reviewed on May 25, 2018

Dosage form: tablet
Ingredients: Aspirin 325mg in 325mg
Labeler: Ajes Pharmaceuticals,LLC
NDC Code: 42787-102

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.

Drug Facts

Active Ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

nonsteroidal antiinflammatory drug

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

Purpose

Pain reliever /  Fever reducer

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

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

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

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

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

VALUE PHARMAPAIN RELIEVER  EXTRA STRENGTH
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42787-102
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin325 mg  in 325 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
STARCH, CORN 
talc 
Titanium Dioxide 
Product Characteristics
Colorwhite (white color) Scoreno score
ShapeROUND (Round Tablet) Size11mm
FlavorImprint CodeC10
Contains    
Packaging
#Item CodePackage Description
1NDC:42787-102-121 BOTTLE (BOTTLE) in 1 CARTON
1325000 mg in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/01/2012
Labeler - Ajes Pharmaceuticals,LLC (159945393)
Establishment
NameAddressID/FEIOperations
Ajes Pharmaceuticals,LLC159945393manufacture(42787-102), relabel(42787-102), repack(42787-102)

 
Ajes Pharmaceuticals,LLC

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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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