Label: ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 28, 2025

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  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • 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
  • SPL UNCLASSIFIED SECTION
    Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901
  • HOW SUPPLIED
    NDC: 71335-0524-1: 30 Tablets in a BOTTLE - NDC: 71335-0524-2: 100 Tablets in a BOTTLE - NDC: 71335-0524-3: 50 Tablets in a BOTTLE - NDC: 71335-0524-4: 60 Tablets in a BOTTLE - NDC: 71335-0524-6: 19 ...
  • PRINCIPAL DISPLAY PANEL
    Acetaminophen ER 650mg Tablet
  • INGREDIENTS AND APPEARANCE
    Product Information