DailyMed - TYLENOL 8 HR ARTHRITIS PAIN (2024)

Table of Contents
View Package Photos Drug Label Info Safety Related Resources More Info For This Drug Drug Label Information Liver warning Allergy alert Do not use Stop use and ask a doctor if Overdose warning Find additional resources Safety Related Resources More Info on this Drug View Labeling Archives for this drug TYLENOL 8 HR ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release RxNorm TYLENOL 8 HR ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release Get Label RSS Feed for this Drug TYLENOL 8 HR ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release NDC Codes TYLENOL 8 HR ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release
  • Label RSS
  • NDC Code(s): 50580-575-01, 50580-575-02, 50580-575-03, 50580-575-06
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 9, 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:
      • minor pain of arthritis
      • muscular aches
      • backache
      • premenstrual and menstrual cramps
      • the common cold
      • headache
      • toothache
    • temporarily reduces fever
    See Also
    Apap: Uses, Dosage, Side Effects, FAQ - MedicinesFAQAcetaminophen: Dosage, Mechanism/Onset of Action, Half-Life - Medicine.comDailyMed - ACETAMINOPHEN - APAP ARTHRITISDailyMed - ACETAMINOPHEN tablet, extended release
  • 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
    • 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
    under 18 years of age
    • ask a doctor
  • 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

    hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

    See Also
    Which Type of Tylenol Should You Take?

  • Questions or comments?

    call 1-800-458-2014 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-575-03

    TYLENOL ® 8HR

    ARTHRITIS PAIN

    Acetaminophen
    Extended-release tablets

    Pain Reliever / Fever Reducer

    For The Temporary Relief
    Of Minor Arthritis Pain

    *Capsule-Shaped
    Bi-Layer Tablets

    Actual Size

    100 Caplets*
    650 mg each

    DailyMed - TYLENOL 8 HR ARTHRITIS PAIN (2)

  • INGREDIENTS AND APPEARANCE
    TYLENOL 8 HR ARTHRITIS PAIN
    acetaminophen tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-575
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
    MAGNESIUM STEARATE (UNII: 70097M6I30)
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
    POVIDONE K30 (UNII: U725QWY32X)
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
    STEARIC ACID (UNII: 4ELV7Z65AP)
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code TYLENOL;ER
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-575-011 in 1 CARTON01/30/2024
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50580-575-021 in 1 CARTON01/30/2024
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:50580-575-031 in 1 CARTON01/30/2024
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:50580-575-061 in 1 CARTON01/30/2024
    4225 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21154401/30/2024

    Labeler -Kenvue Brands LLC(118772437)

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Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!

View Labeling Archives for this drug

TYLENOL 8 HR ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release

Number of versions: 3

Published Date (What is this?) Version Files
Nov 4, 2024 3 (current) download
Jan 30, 2024 2 download
Oct 2, 2023 1 download

RxNorm

TYLENOL 8 HR ARTHRITIS PAIN- 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 8 HR ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release

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NDC Codes

TYLENOL 8 HR ARTHRITIS PAIN- 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 50580-575-01
2 50580-575-02
3 50580-575-03
4 50580-575-06
DailyMed - TYLENOL 8 HR ARTHRITIS PAIN (2024)
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