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Aspirin by PureTek Corporation

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: PureTek Corporation
NDC Code: 59088-120

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)

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief  of minor aches and pains associated with:

  • a cold
  • headache
  • toothache
  • muscular aches
  • backache
  • premenstrual and menstrual cramps
  • minor pain from arthritis
  • and to reduce fever

Warnings

Reye's 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 and 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 severe allergic reaction which may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Stomach bleeding warning:This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause severe stomach bleeding. The chance is higher if you
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning anticoagulant or steroid drug
  • take other drugs containing a prescription or nonprescription NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for longer time than directed

Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • if you are allergic to aspirin

Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding
  • feel faint
  • vomit blood
  • have bloody stools or black stools
  • have stomach pain that does not get better
These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

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

Directions
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 or 2 tablets with water every 4  hours while symptoms persist. Not more than 12 tablets in 24 hours
  • children under 12 years: consult a doctor

Other information
  • store at room temperature, 15 -30° C (59-86° F)
  • do not use if tamper proof seal is open or missing.

Inactive ingredients

microcrystalline cellulose, corn starch and croscarmellose sodium.

Questions or comments

877-921-7873

Front label

Back label

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-120
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeP120
Contains    
Packaging
#Item CodePackage Description
1NDC:59088-120-59100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34307/07/2011
Labeler - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIOperations
PureTek Corporation785961046manufacture, label, pack, outsourcing human drug compounding, repack, relabel

 
PureTek Corporation

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Medically reviewed on Jul 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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