Label: TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-946-04, 52904-946-05, 52904-946-20, 52904-946-25, view more52904-946-30, 52904-946-50 - Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 50580-449
- 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 March 25, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- 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
children under 12 years
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 - do not take more than directed (see overdose warning) adults and children 12 years and over
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Blister Pack
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INGREDIENTS AND APPEARANCE
TYLENOL EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-946(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 (UNII: H8AV0SQX4D) 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:52904-946-04 1 in 1 BLISTER PACK 03/01/1997 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:52904-946-05 2 in 1 BLISTER PACK 03/01/1997 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:52904-946-20 20 in 1 CARTON 03/01/1997 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:52904-946-25 25 in 1 CARTON 03/01/1997 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:52904-946-30 30 in 1 CARTON 03/01/1997 5 2 in 1 POUCH; Type 0: Not a Combination Product 6 NDC:52904-946-50 50 in 1 CARTON 03/01/1997 6 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 NOT FINAL part343 03/01/1997 Labeler - Select Corporation (053805599)