Label: ACETAMINOPHEN tablet
- NDC Code(s): 70000-0036-1, 70000-0410-1, 70000-0410-2
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 22, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Uses
-
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
● more than 4,000 mg of acetaminophen in 24 hours
● with other drugs containing acetaminophen
● 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ● skin reddening ● blisters ● rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
● if you are allergic to acetaminophen or any of the inactive ingredients in this product
-
Directions
● do not take more than directed (see overdose warning)
adults and children 12 years and over:
● take 2 tablets every 6 hours while symptoms last
● do not take more than 6 tablets in 24 hours, unless directed by a doctor
● do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
- Other Information
- INACTIVE INGREDIENT
- Questions or comments?
-
SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Extra Strength.
DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
100% Money Back Guarantee
Return to place of purchase if not satisfied.
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0410 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color white Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code 54;27 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0410-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/05/2018 2 NDC:70000-0410-1 1 in 1 CARTON 12/19/2018 2 60 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 Drug M013 11/05/2018 ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0036 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color white Score 2 pieces Shape ROUND Size 12mm Flavor Imprint Code 54;27 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0036-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/28/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 05/28/2019 Labeler - Cardinal Health (063997360)
