Skip to Content

← See all Leader Aspirin brands

Leader Aspirin by CARDINAL HEALTH

Medically reviewed on September 29, 2017

Dosage form: tablet, chewable
Ingredients: ASPIRIN 81mg
Labeler: CARDINAL HEALTH
NDC Code: 49781-094

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.

Drug Facts

Active ingredient (in each tablet)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

  • for the temporary relief of minor aches and pains or as recommneded by your doctor
  • ask your doctor about other uses for this product

Warning

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

  • facial swelling
  • shock
  • hives
  • asthma (wheezing)

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
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • take more or for a longer time than directed
  • have had stomach ulcers or bleeding problems
  • 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
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have asthma
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease

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
  • 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
  • any new symptoms occur
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs

These could be signs of a serious illness.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
  • store at room temperature (150-300C)
  • aviod excess heat and moisture
  • save carton for full direction and warnings

Inactive ingredients

Corn starch, dextrose monohydrate, FD&c yellow #6, flavor, silicon dioxide, sodium saccharine and stearic acid

Questions or comments?

Adverse drug event call: 1-866-562-2756 

Compare to St. Joseph Chewable Aspirin 81 mg

Leader

Aspirin 81 mg

Pain Reliever (NSAID)

81 mg Chewable

Low Strength Aspirin Regimen

Orange Flavored

LEADER ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-094
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
STEARIC ACID 
FD&C YELLOW NO. 6 
SILICON DIOXIDE 
SACCHARIN SODIUM 
DEXTROSE MONOHYDRATE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint CodePH034
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-094-361 BOTTLE in 1 CARTON
136 TABLET, CHEWABLE (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/20/2014
Labeler - CARDINAL HEALTH (097537435)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

 
CARDINAL HEALTH

← See all Leader Aspirin brands

Further information

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

Hide