Acetaminophen Tablet, Extended Release
FDA Label NDC 0363-0340

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Acetaminophen (NDC 0363-0340). 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 geltab), 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 Geltab)

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

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take

  • more than 6 geltabs 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

  • 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
  • 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
  • the tablet got stuck in your throat

    • 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 geltabs every 8 hours. Swallow only one geltab at a time.
    • take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
    • swallow whole - do not crush, chew, split or dissolve
    • do not take more than 6 geltabs 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 high humidity.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredients

Croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide

Questions?

Call 1-800-406-7984

Principal Display Panel - 650 Mg Geltab Bottle Label

Well at
Walgreens

Arthritis
Pain Reliever

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

• For the temporary relief of minor arthritis pain
• Easy-open bottle • Last up to 8 hours

80 GELTABS*
(*Gelatin-Coated Tablets)

Compare to Tylenol® 8HR Arthritis Pain active ingredient‡‡

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

NDC 0363-0340-08

Principal Display Panel (650 mg Geltab Bottle Label)

Principal Display Panel (650 mg Geltab Bottle Label)

* Please review the disclaimer below.