Label:
NAPROXEN SODIUM HEADACHE PAIN- naproxen sodium tablet, coated
NAPROXEN SODIUM BACK AND MUSCLE PAIN- naproxen sodium table...
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  • NDC Code(s): 43598-071-01, 43598-072-01, 43598-073-01, 43598-074-01
  • Packager: Dr.Reddy's Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 3, 2025

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION
    PAIN RELIEVER / FEVER REDUCER (NSAID) Drug Facts
  • Active ingredient (in each tablet/caplet)
    Naproxen sodium USP, 220 mg - (naproxen USP, 200 mg) (NSAID)1 - 1 - nonsteroidal anti-inflammatory drug
  • Purposes
    Pain reliever/fever reducer
  • Uses
    temporarily relieves minor aches and pains due to: minor pain of arthritis - muscular aches - backache - menstrual cramps - headache - toothache - the common cold - temporarily reduces fever
  • Warnings
    Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives - facial swelling - asthma (wheezing) shock - skin ...
  • Directions
    do not take more than directed - the smallest effective dose should be used - drink a full glass of water with each dose - Adults and children 12 years and older - take 1 tablet/caplet every 8 ...
  • Other information
    each tablet/caplet contains: sodium 20 mg - store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • Inactive ingredients
    FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
  • Questions or comments?
    call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
  • SPL UNCLASSIFIED SECTION
    Distributed by: Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 - Made in India - Rev: 03/2022
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
    Headache Pain - Caplet Container
  • PRINCIPAL DISPLAY PANEL
    Headache Pain - Caplet Carton
  • PRINCIPAL DISPLAY PANEL
    Headache Pain - Tablet Container
  • PRINCIPAL DISPLAY PANEL
    Headache Pain - Tablet Container Carton
  • PRINCIPAL DISPLAY PANEL
    Back and Muscle Pain - Caplet Container
  • PRINCIPAL DISPLAY PANEL
    Back & Muscle Pain - Caplet Container Carton
  • PRINCIPAL DISPLAY PANEL
    Back and Muscle Pain - Tablet Container
  • PRINCIPAL DISPLAY PANEL
    Back and Muscle Pain - Tablet Container Carton
  • INGREDIENTS AND APPEARANCE
    Product Information