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Low Dose Aspirin Enteric Safety Coated

Medically reviewed by Drugs.com. Last updated on Dec 17, 2018.

Dosage form: tablet, delayed release
Ingredients: ASPIRIN 81mg
Labeler: Time-Cap Labs, Inc
NDC Code: 49483-381

Further information

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

381R ASA 81 DR TABS

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*)................................Pain reliever

*nonsteroidal anti-inflammatory drug

anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, d&C yellow #10 aluminum lake,hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, Polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

Purpose: Pain Reliever

Uses

  • temporarily relieves minor aches and pains
  • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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
  • shock
  • asthma (wheezing)

Stomach bleeding warning:

This product contains an 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
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer

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
  • you have asthma
  • you have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug
  • under a doctor's care for any serious condition

Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
  • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

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 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 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package

LOW DOSE ASPIRIN  ENTERIC SAFETY COATED
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-381
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)  
FERRIC OXIDE YELLOW 
PROPYLENE GLYCOL 
SHELLAC 
TALC 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
SODIUM HYDROXIDE 
DIMETHICONE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
STARCH, CORN 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
POLYSORBATE 80 
ANHYDROUS LACTOSE 
FERROSOFERRIC OXIDE 
BROWN IRON OXIDE 
D&C YELLOW NO. 10 
HYPROMELLOSES 
MICROCRYSTALLINE CELLULOSE 
MINERAL OIL 
POTASSIUM HYDROXIDE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeT81
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-381-12120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
2NDC:49483-381-101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/10/2010
Labeler - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIOperations
Time-Cap Labs, Inc037052099manufacture(49483-381)

 
Time-Cap Labs, Inc

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