Label: TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated
- NDC Code(s): 50269-449-25
- Packager: JC World Bell Wholesale Co., Inc.
- This is a repackaged label.
- Source NDC Code(s): 50580-449
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet)
- Uses
-
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take Liver warning:
acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:
If a skin reaction occurs, stop use and seek medical help right away.
- 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
- skin reddening
- blisters
- rash
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 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
TYLENOL EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50269-449(NDC:50580-449) 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 CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POWDERED CELLULOSE (UNII: SMD1X3XO9M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 19mm Flavor Imprint Code TYLENOL;500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50269-449-25 25 in 1 BOX 09/20/2018 1 2 in 1 POUCH; 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 09/20/2018 Labeler - JC World Bell Wholesale Co., Inc. (805257581) Establishment Name Address ID/FEI Business Operations JC World Bell Wholesale Co., Inc. 805257581 repack(50269-449) Establishment Name Address ID/FEI Business Operations McNeil Healthcare LLC 831188763 manufacture(50269-449)