Label: RAPIDOL 500 EXTRA STRENGTH- acetaminophen tablet

  • NDC Code(s): 55758-439-01, 55758-439-50
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 14, 2024

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  • Drug Facts

  • Active ingredient & Purposes

    .

    Active ingredient (in each tablet)Purposes
    Acetaminophen 500 mgPain reliever/ fever reducer
  • Uses

    For the temporary relief of minor aches and pains due to:

    • a cold
    • headache
    • backache
    • muscular aches
    • toothache
    • minor pain of arthritis
    • premenstrual and menstrual cramps
    • and to reduce fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 tablets in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash. If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if allergic to any of the ingredients in this product

    Ask a doctor before use if you have

    • liver disease

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear

    If pregnant or breast feeding,

    ask a health professional before use.

    KEEP OUT OF REACH OF CHILDREN.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    ​

    • ​ do not take more than directed (see LIVER WARNING)
    AgeDose
    adults and children 12 years of age and older
    • take 2 tablets, every 6 hours while symptoms last
    • do not take more than 8 tablets in 24 hours
    children under 12 years of age
    • do not use

  • Other information

    • store between 77-86°F (25-30°C)
  • Inactive ingredients

    croscarmellose sodium, microcrystalline cellulose 101, povidone k30, silicon dioxide, stearic acid

  • Questions or comments?

    +1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

    Dist.by/ por:

    Pharmadel LLC.

    New Castle, DE 19720

  • Prinicipal Display Panel

    Rapidol DPD

  • INGREDIENTS AND APPEARANCE
    RAPIDOL 500  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-439
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Capsule-Shaped Tablet) Size18mm
    FlavorImprint Code A1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-439-5025 in 1 CARTON08/06/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:55758-439-012 in 1 PACKET; Type 0: Not a Combination Product08/01/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/01/2024
    Labeler - Pharmadel LLC (030129680)
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