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- NDC Code(s): 50580-309-01, 50580-309-02
- Packager: Kenvue Brands LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 7, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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- SPL UNCLASSIFIED SECTION
Drug Facts
- Active ingredient (in each caplet)
Acetaminophen 650 mg
- Purpose
Pain reliever/fever reducer
- Uses
- temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
- temporarily reduces fever
- temporarily relieves minor aches and pains due to:
- Warnings
Liver warning
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
- 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
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
- 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
- store between 20-25°C (68-77°F)
- do not use if carton is opened. Do not use if foil inner seal imprinted with "TYLENOL" is broken or missing
- Inactive ingredients
carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, povidone, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
- Questions or comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
- PRINCIPAL DISPLAY PANEL
NDC 50580-309-02
TYLENOL ® 8HR
MUSCLE ACHES & PAINAcetaminophen
Extended-release tabletsPain Reliever / Fever Reducer
For Up to 8 Hours Relief of Minor Muscle Aches & Pain
*Capsule-Shaped Bi-Layer Tablets
Actual Size
100 Caplets*
650 mg each
- INGREDIENTS AND APPEARANCE
TYLENOL 8HR
acetaminophen tablet, film coated, extended releaseProduct 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 650mg 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 -Kenvue Brands LLC(118772437)
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More Info on this Drug
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View Labeling Archives for this drug
TYLENOL 8HR- acetaminophen tablet, film coated, extended release
Number of versions: 9
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Nov 11, 2024 | 9 (current) | download |
| Mar 31, 2023 | 8 | download |
| Oct 11, 2022 | 7 | download |
| Sep 3, 2019 | 6 | download |
| May 3, 2018 | 5 | download |
| Dec 21, 2017 | 4 | download |
| Nov 1, 2016 | 3 | download |
| Oct 4, 2016 | 2 | download |
| Jan 19, 2016 | 1 | download |
RxNorm
TYLENOL 8HR- acetaminophen tablet, film coated, extended release
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN |
| 2 | 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD |
| 3 | 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY |
| 4 | 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY |
| 5 | 1243440 | Tylenol 650 MG 8HR Extended Release Oral Tablet | PSN |
| 6 | 1243440 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol] | SBD |
| 7 | 1243440 | 8 HR APAP 650 MG Extended Release Oral Tablet [Tylenol] | SY |
| 8 | 1243440 | Tylenol 650 MG 8 HR Extended Release Oral Tablet | SY |
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TYLENOL 8HR- acetaminophen tablet, film coated, extended release
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NDC Codes
TYLENOL 8HR- acetaminophen tablet, film coated, extended release
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 50580-309-01 |
| 2 | 50580-309-02 |
