Label: LEADER ASPIRIN- aspirin tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 49781-094-36 - Packager: CARDINAL HEALTH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 29, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- INDICATIONS & USAGE
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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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER ASPIRIN
aspirin tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-094 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) 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 Color orange Score no score Shape ROUND Size 8mm Flavor Imprint Code PH034 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-094-36 1 in 1 CARTON 1 36 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 09/20/2014 Labeler - CARDINAL HEALTH (097537435) Registrant - Pharbest Pharmaceuticals, Inc. (557054835)