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Aspirin 81mg Adult Low Dose by TopCare

Medically reviewed on August 9, 2018

Dosage form: tablet, delayed release
Ingredients: ASPIRIN 81mg
Labeler: TopCare
NDC Code: 36800-880

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.

1080 - TCR - 2016-0809

Drug Facts

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 or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product

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 you have ever had an allergic reaction to 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

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if
  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

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 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 (1-800-222-1222).

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; do not exceed 48 tablets in 24 hours
  • children under 12 years: consult a doctor

Other information
  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

acetylated monoglycerides, anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, hypromellose, hypromellose phthalate, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polyethylene glycol, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

PRINCIPAL DISPLAY PANEL

2 BOTTLES INSIDE

VALUE PACK

TopCare®

NDC 36800-880-08

Adult Low Dose

Aspirin 81mg

Pain Reliever (NSAID)

Quality Guaranteed

Compare to Bayer® Low Dose Aspirin Active Ingredient†

120 Tablets

Enteric Coated

ASPIRIN 81MG   ADULT LOW DOSE
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-880
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DIACETYLATED MONOGLYCERIDES 
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
HYPROMELLOSES 
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) 
BROWN IRON OXIDE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
DIMETHICONE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Codeheart
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-880-082 BOTTLE, PLASTIC in 1 CARTON
1100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/03/2016
Labeler - TopCare (006935977)

 
TopCare

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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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