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ASSURED ASPIRIN

Medically reviewed by Drugs.com. Last updated on Apr 6, 2020.

Dosage form: tablet, delayed release
Ingredients: ASPIRIN 81mg
Labeler: SPIRIT PHARMACEUTICALS LLC
NDC Code: 68210-0015

ASSURED™ ASPIRIN

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 will not provide fast relief of headaches, fever or other symptoms needing immediate relief.
  • ask your doctor about other uses for Aspirin 81 mg

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 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 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

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

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if
  • an allergic reaction occurs. Seek medical 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 more than 10 days
    • redness or swelling is present
    • new symptoms occur
    • 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

Other information
  • each tablet contains: sodium 0.36 mg
  • save carton for full directions and warnings
  • store at room temperature

Inactive ingredients

acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, lactose, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron

Questions or comments?

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DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF
BAYER ® LOW DOSE ASPIRIN*

LOW DOSE
Aspirin

Aspirin (NSAID) 81 mg
Pain Reliever
Actual Size

ASSURED ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0015
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
LACTOSE, UNSPECIFIED FORM 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
WATER 
SODIUM HYDROXIDE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code1
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0015-61 BOTTLE in 1 CARTON
160 TABLET, DELAYED RELEASE in 1 BOTTLE
2NDC:68210-0015-41 BOTTLE in 1 CARTON
240 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/01/2016
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

 
SPIRIT PHARMACEUTICALS LLC

Further information

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