Label: TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 73097-012-02, 73097-012-40, 73097-012-50 - Packager: Savings Distributors LLC
- 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 July 29, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each caplet)
- 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
Ifa 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 ■ take 2 capletes every 6 hours while symptoms
12 years and over: last
■ do not take more than 6 capletes in 24 hours,unless directed by a doctor
■ do not use for more than 10 days unlessdirected by a doctor
children under 12 years ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- Package Labeling
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INGREDIENTS AND APPEARANCE
TYLENOL EXTRA STRENGTH
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73097-012(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 SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 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) 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:73097-012-02 1 in 1 CARTON 07/22/2019 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:73097-012-40 20 in 1 CARTON 07/22/2019 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:73097-012-50 25 in 1 BOX 07/22/2019 3 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 07/22/2019 Labeler - Savings Distributors LLC (010527359) Establishment Name Address ID/FEI Business Operations Savings Distributors LLC 010527359 repack(73097-012)
