Label: TYLENOL 8HR- acetaminophen tablet, film coated, extended release
- NDC Code(s): 50580-309-01, 50580-309-02
- Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 10, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- 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
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
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
- do not take more than directed (see overdose warning)
adults and children 12 years and over
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
children under 12 years
- do not use
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
acetaminophen tablet, film coated, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-309 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) POWDERED CELLULOSE (UNII: SMD1X3XO9M) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white Score no score Shape OVAL Size 21mm Flavor Imprint Code TYLENOL;ER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-309-01 1 in 1 CARTON 01/18/2016 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:50580-309-02 1 in 1 CARTON 01/18/2016 2 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019872 01/18/2016 Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)