NDC | 66715-9747-1, 66715-9747-2, 66715-9747-3, 66715-9747-7 |
Set ID | fa951d50-b79c-4161-8c81-fcf386b0964e |
Category | HUMAN OTC DRUG LABEL |
Packager | Lil' Drug Store Products, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- 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 - 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?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 500 mg Caplet Pouch Carton
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INGREDIENTS AND APPEARANCE
TYLENOL EXTRA STRENGTH
acetaminophen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9747 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) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 18mm Flavor Imprint Code TYLENOL;500 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9747-1 1 in 1 CARTON 04/16/2018 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-9747-2 2 in 1 CARTON 04/13/2019 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:66715-9747-3 3 in 1 CARTON 06/29/2018 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:66715-9747-7 30 in 1 CARTON 04/09/2018 4 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 08/09/2011 Labeler - Lil' Drug Store Products, Inc. (093103646)