Acetaminophen
FDA Label NDC 55319-333

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services, Inc. for the product Acetaminophen (NDC 55319-333). 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.

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC
    500 Volvo Parkway, Chesapeake, VA 23320 USA

Active Ingredient (In Each Caplet)

Acetaminophen USP, 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.

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 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

crospovidone, 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 - 650 Mg Caplet Bottle Carton

FAMILY
wellness™

COMPARE TO
TYLENOL® ARTHRITIS PAIN*

EASY
TO OPEN
BOTTLE

Use only as directed.
NDC 55319-333-01

ARTHRITIS
Pain Relief
Acetaminophen Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer

  • For the Temporary Relief of Minor Arthritis Pain

    • Lasts up to
    8 Hours

    DO NOT USE WITH OTHER
    MEDICINES CONTAINING
    ACETAMINOPHEN

    ACTUAL SIZE

    THIS PACKAGE FOR
    HOUSEHOLDS WITHOUT
    YOUNG CHILDREN

    100% SATISFACTION
    OR YOUR MONEY BACK
    GUARANTEED

    100 CAPLETS* (*Capsule-Shaped Tablets)

    Principal Display Panel (650 mg Caplet Bottle Carton)

    Principal Display Panel (650 mg Caplet Bottle Carton)

* Please review the disclaimer below.