Acetaminophen 8 Hour
FDA Label NDC 59779-336

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Acetaminophen 8 Hour (NDC 59779-336). 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 active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • headache
    • minor pain of arthritis
      • temporarily reduces fever

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

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 at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • see end panel for batch number and expiration date
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredients

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

Call 1-800-406-7984

Principal Display Panel

CVS pharmacy®

Compare to the active ingredient in Tylenol®8 Hour†

Use only as directed.

See New Warnings Information

Lasts up to 8 Hour

GLUTEN FREE

DYE FREE

PAIN RELIEF

CAPLETS*

ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg

  • Pain Reliever/Fever Reducer
  • For up to 8 Hour Relief of Minor Muscular Aches & Pain

    • 100 CAPLETS*

    650 mg EACH

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    (*Capsule-Shaped Tablets)

    Distributed by: CVS Pharmacy, Inc.

    5095677/R0512

    100's Bottle Carton Label (Apap8hr)

    100's Bottle Carton Label (Apap8hr)

* Please review the disclaimer below.