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 August 27, 2019
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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 (140 MPA.S AT 5%) (UNII: 8136Y38GY5) 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 Potato (UNII: 5856J3G2A2) 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)