Label: LEADER ASPIRIN- aspirin tablet, chewable
- NDC Code(s): 70000-0420-1, 70000-0420-2
- Packager: Cardinal Health 110, LLC. dba Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated March 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
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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:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do not use
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
Ask a doctor before use if
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you are taking a diuretic
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- you have asthma
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
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- gout
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- diabetes
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- arthritis
Stop use and ask a doctor if
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- an allergic reaction occurs. Seek medical help right away.
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- ringing in the ears or a loss of hearing occurs
These could be signs of a serious condition
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
LEADER™
Chewable Aspirin
81 mg Tablets | Pain Reliever (NSAID)
COMPARE TO BAYER® CHEWABLE LOW DOSE ASPIRIN
active ingredient
Orange Flavored
Low Dose Aspirin Regimen
Talk to Your Doctor or Other Healthcare Provider before Using This Product for Your Heart
Actual Size
100% Money Back Guarantee
36 TABLETS
SEE NEW WARNING
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INGREDIENTS AND APPEARANCE
LEADER ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0420 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color ORANGE Score no score Shape ROUND Size 8mm Flavor ORANGE Imprint Code L467 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0420-1 1 in 1 CARTON 08/13/2018 1 36 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:70000-0420-2 3 in 1 CARTON 08/13/2018 11/30/2021 2 36 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/13/2018 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)
