Tylenol 8 Hr Arthritis Pain Tablet, Extended Release
FDA Label NDC 50580-783

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Tylenol 8 Hr Arthritis Pain (NDC 50580-783). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each caplet), purpose, uses, liver warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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.

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

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

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

Otc - Ask Doctor

Ask a doctor before use if you have liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 or if neck wrap or 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 50580-783-25

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

225 Caplets*
650 mg each

Principal Display Panel (Tylenol 01)

Principal Display Panel (Tylenol 01)

* Please review the disclaimer below.