Label: RAPIDOL ASPIRIN DISPLAY 2X25- aspirin tablet, coated

  • NDC Code(s): 55758-362-02, 55758-362-50
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 10, 2022

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  • Drug Facts

  • Active ingredient and Purpose

    Active ingredient

    (in each tablet)

    		Purpose

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

    *nonsteroidal anti-inflammatory drug

    		Pain reliever

  • Uses


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

    • a cold
    • a headache
    • a toothache
    • muscular aches
    • a backache
    • minor pains of arthritis
  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

    • hives
    • shock
    • facial swelling
    • asthma (wheezing)

    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:

    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescriptionNSAIDs (aspirin, ibuprofen, naproxen, or others)
    • take more or for a longer time than directed
    • are age 60 or older
    • have 3 or more alcoholic drinks everyday while using this product

    Do not use

    if you are allergic to aspirin or any other pain reliever/fever reducer.

    Ask a doctor before use if

    • 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
    • you have not been drinking fluids
    • you have lost a lot of fluid due to vomiting or diarrhea
    • you are taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

    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 persist, gets worse or last for more than 10 days
    • ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.
    It is very important not to use aspirin during the last 3 months of pregnancy unless 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

    • do not take more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years of age and over:
    • take two (2) tablet every 4 hours
    • do not take more than 6 doses in 24 hours
    • children under 12 years of age: consult a doctor
  • Other information

    • store between 68-77˚F (20-25˚C) in a dry place
    • use by expiration date on package

    TAMPER EVIDENT: Do not use if individual packets are broken or torn.

  • 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

    NDC 55758-312-50

    NDC 55758-312-02

    Rapidol

    Aspirin/Aspirina

    325 mg

    Alivia Dolor (AINE*) Pain Reliever (NSAID*)

    Relieves / Alivia


    ✓ Headaches/ Dolor de Cabeza
    ✓ Muscular Pain/ Dolores Musculares
    ✓ Minor Arthritis Pain/ Dolores de Artritis Leves

    SIN CAFEINA / CAFFEINE FREE

    25 Sobres x 2 Tabletas 25 packets of 2 tablets each

    Pouch

    Aspirin Box

  • INGREDIENTS AND APPEARANCE
    RAPIDOL ASPIRIN DISPLAY 2X25 
    aspirin tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-362
    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:55758-362-5025 in 1 CARTON08/10/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:55758-362-022 in 1 PACKET; Type 0: Not a Combination Product08/10/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34308/10/2022
    Labeler - Pharmadel LLC (030129680)
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