Label: CALMADOL PAIN RELIEVER- naproxen sodium tablet

  • NDC Code(s): 48201-007-24
  • Packager: GRANDALL DISTRIBUTING, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 23, 2024

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  • Active Ingredients (in each tablet)
    Naproxen sodium 220 mg - (naproxen 200 mg)(NSAID)*
  • Purpose
    Pain reliever/ fever reducer
  • Uses
    ■ temporarily relieves minor aches and pains due to: ■ headache ■ common cold ■ muscular aches - ■backache ■ toothache ■ menstrual cramps - ■minor pain of arthritis - ■temporarily reduces fever
  • PREGNANCY OR BREAST FEEDING
    If pregnant or breast-feeding, ask a health professional before use. It is especially - important not to use naproxen sodium during - the last 3 months of pregnancy unless - definitely directed to do so ...
  • KEEP OUT OF REACH OF CHILDREN.
    In case of overdose, get medical help or contact a Poison Control Center right away.
  • 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 every 8 to 12 ...
  • Other information:
    Each tablet contains sodium 20 mg. Store at 20-25 C (68-77ºF) Avoid high humidity and excessive heat above 40ºC (104ºF). Keep Carton.
  • Questions
    If you have questions of a medical nature, please conact your pharmacist, doctor or health care professional.
  • SPL UNCLASSIFIED SECTION
    Distributed by: Grandall Distributing Co., Inc. Glendale, CA 91204-2707
  • Inactive ingredients
    colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline, cellulose, polyethylene glycol, povidone, titanium dioxide
  • Package Labeling
    CALMADOL - PAIN RELIEVER - FEVER REDUCER - Naproxen Sodium Tablets - 220 mg (NSAID) 24 TABLETS
  • INGREDIENTS AND APPEARANCE
    Product Information