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Adult Low Dose Enteric Coated Aspirin

Medically reviewed on August 22, 2017

Dosage form: tablet, coated
Ingredients: ASPIRIN 81mg
Labeler: TYA Pharmaceuticals
NDC Code: 64725-0981

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.

Active ingredient (in each tablet)

Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses
  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin

Warnings

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: 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 child or complications during delivery.

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. Reye's Syndrome:

Aspirin may cause a severe allergic reaction which may include: Allergy Alert:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Stomach bleeding warning:
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

if your are allergic to aspirin or any other pain reliever/fever reducer. Do not use

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis  -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs
If pregnant or breast-feeding,

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

Directions
  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • do not exceed recommended dose
  • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information
  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only

Inactive ingredients

cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose, phthalate, lactose, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.

ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED
ADULT LOW DOSE ENTERIC COATED ASPIRIN  
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-0981(NDC:50844-600)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
METHACRYLIC ACID 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
SHELLAC 
SILICON DIOXIDE 
DIMETHICONE 
SODIUM BICARBONATE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeL
Contains    
Packaging
#Item CodePackage Description
1NDC:64725-0981-1100 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34307/01/2000
Labeler - TYA Pharmaceuticals (938389038)
Registrant - TYA Pharmaceuticals (938389038)
Establishment
NameAddressID/FEIOperations
TYA Pharmaceuticals938389038RELABEL(64725-0981), REPACK(64725-0981)

 
TYA Pharmaceuticals

← See all Adult Low Dose Enteric Coated Aspirin brands

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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