Label: RAPIDOL NAPROXEN- naproxen sodium tablet, coated

  • NDC Code(s): 55758-048-02, 55758-048-24, 55758-048-50
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

    Drug Facts

  • Active ingredient and Purposes

    Active ingredient (in each caplet) Purposes

    Naproxen sodium 220mg

    (naproxen 200mg) (NSAID*)

    		Pain reliver/ fever reducer
    *nonsteroidal anti-inflammatory drug

  • Uses

    • temporarily relieves minor aches and pains due to
    • minor pain from arthritis
    • menstrual cramps
    • muscular aches
    • headache
    • backache
    • toothache
    • the common cold
    • temporarily reduces fever
  • Warnings

    Allergy alert: Naproxen sodium may cause severe skin reactions. Symptoms may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • skin reddening
    • rash
    • blisters. 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

    Heart attack and stroke warning:NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers

    Ask a doctor or pharmacist before use if you are

    • under a doctor’s care for any serious condition
    • taking any other drugs
    • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin

    When using this product

    • take with food or milk if stomach upset occurs

    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
    • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • slurred speech
    • leg swelling
    • weakness in one part or side of body

    • 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

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later 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.

  • Other information

    • each caplet contains: sodium 20 mg
    • store between 68-77°F (20-25°C). Avoid high humidity and excessive heat above 104°F (40°C)
    • keep carton for complete warnings and information
  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • drink a full glass of water with each dose

    adults & children 12 years of age and older

    • take 1 caplet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 caplets within the first hour
    • do not exceed 2 caplets in any 8 to 12 hour period
    • do not exceed 3 caplets in a 24-hour period
    children under 12 years of age

    consult a doctor

  • Inactive ingredients

    corn starch, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, water

  • Distributed by/ Distribuido por:

    PHARMADEL LLC

    New Castle, DE 19720

    Questions? +1-866-359-3478

    Made in India/ Hecho en India

    †This product is not manufactured or distributed by Bayer Health Care LLC., distributor of Aleve® caplets. Aleve® is a registered mark of Bayer Health Care LLC.

  • Prrinicpal Display Panel

    PDP NAPROXENO

  • INGREDIENTS AND APPEARANCE
    RAPIDOL NAPROXEN 
    naproxen sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-048
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblue (Light Blue) Scorescore with uneven pieces
    ShapeOVAL ((Caplet Shaped)) Size12mm
    FlavorImprint Code 220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-048-241 in 1 CARTON10/09/2019
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55758-048-5025 in 1 CARTON10/24/2023
    2NDC:55758-048-022 in 1 PACKET; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09135310/09/2019
    Labeler - Pharmadel LLC (030129680)
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