Label: RAPIDOL ASPIRIN- aspirin tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 17, 2023

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  • Drug Facts

  • Active ingredient and Purpose

    Active ingredient

    (in each tablet)

    		Purposes

    Aspirin 325 mg (NSAID*).............................

    *nonsteroidal anti-inflammatory drug

    		Pain reliever/ fever reducer
  • Uses


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

    • cold
    • headache
    • toothache
    • muscular aches
    • backache
    • minor pains from arthritis
    • and to reduce fever

  • Warnings

    Do not use

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

    Ask a doctor before use if

    • you have asthma
    • 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, or kidney disease
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if

    you are taking a prescription drug for

    • diabetes
    • gout
    • arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right

    away.

    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
    • ringing in the ears or a loss of hearing occurs

    • pain gets worse or last for more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin 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.

  • Directions

    • adults and children 12 years of age and over:
    • drink a full glass of water with each dose
    • take one (1) or two (2) tablets every 4 hours, while symptoms persist
    • do not take more than 12 tablets in 24 hours

    • children under 12 years of age: consult a doctor
  • Other information

    • store between 68-77˚F (20-25˚C)
  • Inactive ingredients

    corn starch, hypromellose, polyethylene glycol, povidone, talc, titanium dioxide

  • Questions or comments?

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

  • Principal Display Panel

    PDP Rapidol A 325

  • INGREDIENTS AND APPEARANCE
    RAPIDOL ASPIRIN 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-363
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize10mm
    FlavorImprint Code ASP325
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-363-601 in 1 CARTON08/01/2023
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/01/2023
    Labeler - Pharmadel LLC (030129680)
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