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Aspirin 81 mg Enteric Coated by Reliable 1 Laboratories LLC

Medically reviewed on November 1, 2017

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: Reliable 1 Laboratories LLC
NDC Code: 69618-017

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.

Aspirin USP 81 mg Enteric Coated Tablet

Drug Facts

Active ingredient (in each tablet)

Aspirin USP, 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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 you 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 comiting 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 steriod drug
  • take other drugs containing prescription or non-prescription NSAIDs (ibuprofen, naproxen, or others)
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

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

Drug Facts continued on back of label

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

Ask a doctor or pharmacist before use if you are

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

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • 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 ear or loss of hearing occurs

these could be sings 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 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complictions 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 & older: take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information
  • store at room temperature 15°-30°C (59°-86°F)

croscarmellose sodium, D&C yellow #10 (Al-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, corn strach, stearic acid, talc, titanium dioxide

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

NDC 69618-017-02

Enteric Coated

Aspirin USP 81 mg (NSAID)

Adult Low Strength

PAIN RELIEVER

120 TABLETS

*Compare to Active Ingredient in Aspirin Regimen BAYER®

ASPIRIN 81 MG ENTERIC COATED 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-017
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
METHACRYLIC ACID 
D&C YELLOW NO. 10 
POLYETHYLENE GLYCOL 1000 
SILICON DIOXIDE 
TALC 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
POVIDONE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeAP;121
Contains    
Packaging
#Item CodePackage Description
1NDC:69618-017-02120 TABLET in 1 BOTTLE, PLASTIC
2NDC:69618-017-101000 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34311/01/2015
Labeler - Reliable 1 Laboratories LLC (079718111)

 
Reliable 1 Laboratories LLC

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Further information

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

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