Label: ADULT ASPIRIN REGIMEN- aspirin tablet, film coated
- NDC Code(s): 70000-0178-1, 70000-0178-2, 70000-0178-3
- 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 August 27, 2022
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 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:
- hives
- shock
- facial swelling
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- 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
- take a blood thinning (anticoagulant) or steroid drug
- have 3 or more alcoholic drinks every day while using this product
- are age 60 or older
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 have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you are taking a diuretic
- 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
- feel faint
- have bloody or black stools
- 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
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
LEADER™
NDC 70000-0178-3
Low Dose | Safety Coated
Adult Aspirin Regimen**
Tablets, 81 mg | Pain Reliever (NSAID)**Talk to Your Doctor or Other Healthcare Provider Before Using This Product for Your Heart.
120
ENTERIC COATED
TABLETSActual Size
COMPARE TO BAYER® LOW DOSE ASPIRIN active ingredient†
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
CIN 5528153 REV. 6/19
†This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Bayer® Low Dose Aspirin.
50844 ORG031860032
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OH 43017
www.myleader.com 1-800-200-6313© 2019 Cardinal Health.
100% Money Back Guarantee
Return to place of purchase.
Leader 44-600A
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INGREDIENTS AND APPEARANCE
ADULT ASPIRIN REGIMEN
aspirin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0178 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) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) METHACRYLIC ACID (UNII: 1CS02G8656) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) SHELLAC (UNII: 46N107B71O) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow Score no score Shape ROUND Size 6mm Flavor Imprint Code L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0178-2 300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2011 06/22/2024 2 NDC:70000-0178-3 1 in 1 CARTON 05/01/2011 06/22/2024 2 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:70000-0178-1 1 in 1 CARTON 05/01/2011 06/22/2024 3 32 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 05/01/2011 06/22/2024 Labeler - Cardinal Health 110, LLC. DBA Leader (063997360) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(70000-0178) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(70000-0178) , pack(70000-0178) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(70000-0178)