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← See all Adult Low Dose Enteric Coated Aspirin brands

Adult Low Dose Enteric Coated Aspirin

Medically reviewed on January 1, 2018

Dosage form: tablet, coated
Ingredients: ASPIRIN 81mg
Labeler: REMEDYREPACK INC.
NDC Code: 61786-532

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.

OTC - ACTIVE INGREDIENT

Aspirin 81 mg(NSAID)*

*nonsteroidal anti-inflammatory drug

 

OTC - PURPOSE

Pain reliever

 

INDICATIONS & USAGE

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

 

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 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
  • 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

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

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,

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.

 

DOSAGE & ADMINISTRATION

  • 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

 

STORAGE AND HANDLING

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

 

INACTIVE INGREDIENT

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.

 

OTC - KEEP OUT OF REACH OF CHILDREN



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Adult Low Dose Enteric Coated Aspirin


GENERIC: Aspirin


DOSAGE: TABLET, COATED


ADMINSTRATION: ORAL


NDC: 61786-532-02


ACTIVE INGREDIENT(S):

  • ASPIRIN 81mg in 1


INACTIVE INGREDIENT(S):

  • DIMETHICONE
  • FERROSOFERRIC OXIDE
  • SILICON DIOXIDE
  • SODIUM BICARBONATE
  • SHELLAC
  • SODIUM LAURYL SULFATE
  • TRIACETIN
  • TALC
  • TITANIUM DIOXIDE
  • PROPYLENE GLYCOL
  • D&C YELLOW NO. 10
  • FD&C YELLOW NO. 6
  • HYPROMELLOSES
  • STARCH, CORN
  • POLYETHYLENE GLYCOLS
  • CELLULOSE, MICROCRYSTALLINE
  • POLYDEXTROSE
  • METHACRYLIC ACID
  • TRIETHYL CITRATE


COLOR: yellow


SHAPE: ROUND


SCORE: No score


SIZE: 6 mm


IMPRINT: L


PACKAGING: 30 in 1 BLISTER PACK




ADULT LOW DOSE ENTERIC COATED ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-532(NDC:57896-981)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
FERROSOFERRIC OXIDE 
SILICON DIOXIDE 
SODIUM BICARBONATE 
SHELLAC 
SODIUM LAURYL SULFATE 
TRIACETIN 
TALC 
TITANIUM DIOXIDE 
PROPYLENE GLYCOL 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
STARCH, CORN 
POLYETHYLENE GLYCOLS 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
METHACRYLIC ACID 
TRIETHYL CITRATE 
Product Characteristics
ColoryellowScoreno score
ShapeROUND (TABLET, COATED) Size6mm
FlavorImprint CodeL
Contains    
Packaging
#Item CodePackage Description
1NDC:61786-532-0230 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/30/2015
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

← 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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