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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Drug Facts

Active ingredient (in each tablet)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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

 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

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

image of label

LEADER ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-094
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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint Code PH034
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-094-361 in 1 CARTON
136 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)

Revised: 9/2014
Document Id: 9a159f37-c369-493d-9d4b-fedf6a4f2280
Set id: 60581362-83da-4da3-b8ce-b07e3e3a1102
Version: 1
Effective Time: 20140929
 
CARDINAL HEALTH