Label: RAPIDOL STOMACH RELIEF- bismuth subsalicylate liquid

  • NDC Code(s): 55758-331-07, 55758-331-08
  • 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 February 7, 2023

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  • Drug Facts

    Drug Facts

  • Active ingredient & Purposes

    Active ingredient
    (in each 30 mL dose cup or 2 tablespoons)

    		Purposes
    Bismuth subsalicylate 525 mg.................Upset stomach reliever and antidiarrhea
  • Uses

    relieves

    • travelers' diarrhea
    • diarrhea
    • upset stomach due to overindulgence of food and drink including:
    • heart burn
    • indigestion
    • nausea
    • gas
    • belching
  • 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: contains salicylate. Do not take if you are

    • allergic to salicylates (including aspirin)
    • taking other salicylate products

    Do not use if you have

    • an ulcer
    • a bleeding problem
    • black or bloody stool

    Ask a doctor before use if you have

    • fever
    • mucus in stool

    Ask a doctor or pharmacist before use if you are taking any drug for

    • anticoagulation (thinning of the blood)
    • diabetes
    • gout
    • arthritis

    When using this product

    a temporary, but harmless, darkening of the stool and/or tongue may occur.

    Slop use and ask a doctor if

    • diarrhea lasts more than 2 days
    • symptoms get worse or last more than 2 days
    • ringing in the ears or loss of hearing occurs

    If pregnant or breast feeding,

    ask 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.

  • Directions

    • shake well before use
    • use dose cup or tablespoon (TBSP)
    • adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour or every hour as needed
    • do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours
    • use until diarrhea stops but not more than 2 days
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • children under 12 years: ask adoctor



  • Other information

    • each 30 mL dose contains: magnesium45 mg, sodium 13 mg, salicylate 256 mg
    • protect from freezing
    • avoid excessive heat (over 104ºF or 40ºC)
    • low sodium
  • Inactive ingredients

    benzoic acid, D&C red #22, D&C red #28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum

  • Questions?

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

  • Distributed by:

    PHARMADEL LLC.

    New Castle, DE 19720

  • Prinicpal Display Panel

    NDC 55758-331-07

    Rapidol Stomach Relief 8 FL OZ (237 mL)

    Rapidol Stomach Relief PDP

  • INGREDIENTS AND APPEARANCE
    RAPIDOL STOMACH RELIEF 
    bismuth subsalicylate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorpink (color suspension) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-331-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/202212/08/2022
    2NDC:55758-331-07237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33512/08/2022
    Labeler - Pharmadel LLC (030129680)
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