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Aspirin by Sunrise Pharmaceutical Inc

Dosage form: tablet, delayed release
Ingredients: ASPIRIN 81mg
Labeler: Sunrise Pharmaceutical Inc
NDC Code: 11534-073

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.

Unknown Title

OTC - ACTIVE INGREDIENT

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE

Pain reliever

INDICATIONS AND USAGE
  • for the temporary relief of minor aches and pains or as recommended by your doctor.

Because of its delayed release action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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 everyday while using this product
  • take more or for a longer time than directed

OTC - DO NOT USE

If you are allergic to aspirin or any other pain reliever/fever reducer.

OTC - 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

OTC - ASK A DOCTOR/PHARMACIST BEFORE USE IF YOU ARE

taking a prescription drug for:

  • Gout
  • Diabetes
  • arthritis

OTC - 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
  • allergic reaction occurs. Seek medical help right away.
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

OTC - 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. 

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION
  • 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
  • store at 15°-30°C (59°-86°F)
  • do not use if seal on the carton is missing or damaged

INACTIVE INGREDIENT

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil,  polyethylene glycol, propylene glycol, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-073
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSE 2208 (100 MPA.S) 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
TALC 
CROSCARMELLOSE SODIUM 
PROPYLENE GLYCOL 
SODIUM BICARBONATE 
SODIUM LAURYL SULFATE 
TRIACETIN 
TRIETHYL CITRATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeSP;03
Contains    
Packaging
#Item CodePackage Description
1NDC:11534-073-11120 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE
2NDC:11534-073-0557603 TABLET, DELAYED RELEASE (TABLET) in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/26/2005
Labeler - Sunrise Pharmaceutical Inc (168522378)

 
Sunrise Pharmaceutical Inc

← See all Aspirin brands

Medically reviewed on Aug 1, 2018

Further information

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

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