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

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

  • 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 by a doctor

    because it may cause problems in the unborn

    child or complications during delivery.

  • 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 reddening ■ blisters ■ rash

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning:

    This product contains an NSAID, which may cause severe stomach bleeding.

    The chance is higher if you

    ■ are age 60 or older

    ■ have had stomach ulcers or bleeding problems

    ■ take a blood thinning (anticoagulant) or steroid drug

    ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

    ■ have 3 or more alcoholic drinks every day while using this product

    ■ take more or for a longer time than directed

    Do not use

    ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

    ■ right before or after heart surgery

    Ask a doctor before use if

    ■ the stomach bleeding warning applies to you

    ■ you have a history of stomach problems, such as heartburn

    ■ you have problems or serious side effects from taking pain relievers or fever reducers

    ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

    ■ you are taking a diuretic

    ■ you have asthma

    Ask a doctor or pharmacist before use if you are

    ■ under a doctor's care for any serious condition

    ■ taking any other drug When using this product

    ■ take with food or milk if stomach upset occurs

    ■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    Stop use and ask a doctor if

    ■ you experience any of the following signs of stomach bleeding:

    ■ feel faint ■ vomit blood

    ■ have bloody or black stools

    ■ have stomach pain that does not get better

    ■ pain gets worse or lasts more than 10 days

    ■ fever gets worse or lasts more than 3 days

    ■ you have difficulty swallowing

    ■ it feels like the pill is stuck in your throat

    ■ redness or swelling is present in the painful area

    ■ any new symptoms appear

  • 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 hours while

    symptoms last

    ■ for the first dose you may take 2 tablets within the first hour

    ■ do not exceed 2 tablets in any 8 to 12-hour period

    ■ do not exceed 3 tablets in a 24-hour period

    ■ Children under 12 years: Ask a doctor

  • 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

    CalmadolTabLabel.jpg

    OuterCarton

  • INGREDIENTS AND APPEARANCE
    CALMADOL PAIN RELIEVER 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48201-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48201-007-241 in 1 BOX03/31/2015
    124 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054503/31/2015
    Labeler - GRANDALL DISTRIBUTING, LLC (044428324)