Cardinal Health Aspirin 81 mg Drug Facts

leader aspirin by

Drug Labeling and Warnings

leader aspirin by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER ASPIRIN- aspirin tablet, chewable 
Cardinal Health

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.

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Cardinal Health Aspirin 81 mg 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

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
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • 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

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
  • fever gets worse or lasts for more than 3 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 not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Other information

  • store at 20-25°C (68-77°F)

Inactive ingredients

corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Bayer® Chewable Aspirin active ingredient

LOW DOSE

Aspirin

81 mg

Chewable Orange

Aspirin Regimen**

Pain Reliever (NSAID)

Actual Size

Aspirin Carton Image 1
Aspirin Carton Image 2
LEADER ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37205-467
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code L467
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37205-467-681 in 1 CARTON08/09/199302/06/2020
136 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/09/199302/06/2020
Labeler - Cardinal Health (097537435)

Revised: 12/2018
 
Cardinal Health