Label: ASPIRIN tablet, film coated
- NDC Code(s): 70000-0253-1, 70000-0253-2, 70000-0253-3, 70000-0253-4
- Packager: Cardinal Health 110, LLC. DBA Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 25, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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:
- 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
- have 3 or more alcoholic drinks every day while using this product
- have had stomach ulcers or bleeding problems
- take more or for a longer time than directed
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
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
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- vomit blood
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
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Directions
- do not take more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
LEADER™
NDC 70000-0253-2
Genuine
Aspirin
Tablets, 325 mg | Pain Reliever
Fever Reducer (NSAID)Actual Size
100
TABLETSCOMPARE TO
GENUINE BAYER®
ASPIRIN
active ingredient†100% Money
Back GuaranteeTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING†This product is not manufactured or distributed by Bayer AG, owner of the registered
trademark Genuine Bayer® Aspirin. 50844 REV0122B15712©2022 CARDINAL HEALTH,
LEADER, and LOGOs are
trademarks of Cardinal Health.
All other marks are the property
of their respective owners.100% Money Back Guarantee
Return to place of purchase if not satisfied.DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Leader 44-157
-
INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0253 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code Aspirin;44;157 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0253-2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/10/1996 2 NDC:70000-0253-4 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/10/1996 3 NDC:70000-0253-1 1 in 1 CARTON 02/10/1996 01/14/2021 3 50 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:70000-0253-3 300 in 1 BOTTLE; Type 0: Not a Combination Product 02/10/1996 10/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/10/1996 Labeler - Cardinal Health 110, LLC. DBA Leader (063997360) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(70000-0253) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(70000-0253) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(70000-0253) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(70000-0253) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(70000-0253)