Label: TYLENOL EXTRA STRENGTH- acetaminophen tablet, coated
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NDC Code(s):
50580-488-01,
50580-488-10,
50580-488-24,
50580-488-25, view more50580-488-28, 50580-488-52
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
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 March 22, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each gelcap)
- 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
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do not take more than directed
(see overdose warning)
adults and children 12 years and over - take 2 gelcaps every 6 hours while symptoms last
- do not take more than 6 gelcaps 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 -
do not take more than directed
- Other information
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Inactive ingredients
benzyl alcohol, butylparaben, carboxymethylcellulose sodium, D&C yellow no. 10, edetate calcium disodium, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TYLENOL EXTRA STRENGTH
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-488 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 BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MAGNESIUM STEARATE (UNII: 70097M6I30) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POWDERED CELLULOSE (UNII: SMD1X3XO9M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PROPIONATE (UNII: DK6Y9P42IN) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color blue, gray, red Score no score Shape OVAL Size 21mm Flavor Imprint Code TY;500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-488-10 1 in 1 CARTON 01/16/2017 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:50580-488-24 1 in 1 CARTON 01/16/2017 2 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:50580-488-25 1 in 1 CARTON 01/16/2017 3 225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:50580-488-28 290 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/16/2017 5 NDC:50580-488-01 50 in 1 TRAY 04/17/2017 12/31/2018 5 2 in 1 POUCH; Type 0: Not a Combination Product 6 NDC:50580-488-52 1 in 1 CARTON 06/17/2019 6 50 in 1 BOTTLE, PLASTIC; 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 01/16/2017 Labeler - Johnson & Johnson Consumer Inc. (878046358)