DrugCite

ASPIRIN  - aspirin tablet 
PureTek Corporation

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

image of front  label

Back label

image of back label


ASPIRIN 
aspirin  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 59088-120
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
CROSCARMELLOSE SODIUM  
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code P120
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 59088-120-59 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 07/07/2011

Labeler - PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 manufacture, label, pack, outsourcing human drug compounding, repack, relabel
Revised: 07/2011PureTek Corporation