NDC | 50580-590-01, 50580-590-02, 50580-590-03 |
Set ID | 015a6179-bacb-452d-b594-4de628ddc11d |
Category | HUMAN OTC DRUG LABEL |
Packager | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
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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 use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor - Other information
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Inactive ingredients
carnauba wax, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, modified starch1, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, purified water, sodium starch glycolate, sucralose, titanium dioxide
- 1
- may contain
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TYLENOL EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-590 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) FD&C red no. 40 (UNII: WZB9127XOA) FD&C yellow no. 6 (UNII: H77VEI93A8) aluminum oxide (UNII: LMI26O6933) hypromellose, unspecified (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) magnesium stearate (UNII: 70097M6I30) polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A) polysorbate 80 (UNII: 6OZP39ZG8H) powdered cellulose (UNII: SMD1X3XO9M) water (UNII: 059QF0KO0R) sodium starch glycolate type a potato (UNII: 5856J3G2A2) sucralose (UNII: 96K6UQ3ZD4) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND Size 12mm Flavor Imprint Code TYLENOL;500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-590-01 1 in 1 CARTON 07/16/2018 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:50580-590-02 1 in 1 CARTON 07/16/2018 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:50580-590-03 1 in 1 CARTON 07/16/2018 3 225 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:50580-590-04 1 in 1 CARTON 07/31/2020 4 24 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:50580-590-05 1 in 1 CARTON 07/31/2020 5 100 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:50580-590-06 1 in 1 CARTON 07/31/2020 6 225 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 07/16/2018 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)