Label: DRX CHOICE STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate suspension

  • NDC Code(s): 68163-707-12
  • Packager: RARITAN PHAMACEUTICALS INC
  • 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 September 2, 2023

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  • Active ingredient (in each 15 mL dose)

    Bismuth subsalicylate 525 mg

  • Purposes

    Upset stomach reliever and antidiarrheal

  • Uses

    relieves

    ▪
    travelers’ diarrhea
    ▪
    diarrhea
    ▪
    upset stomach due to overindulgence in food and drink, including:
    ▪
    heartburn
    ▪
    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 or 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
    ▪
    bloody or black stool

    Ask a doctor before use if you have

    ▪
    fever
    ▪
    mucus in the stool

    Ask a doctor or pharmacist before use if you are

    taking any drug for

    ▪
    anticoagulation (thinning the blood)
    ▪
    diabetes
    ▪
    gout
    ▪
    arthritis

    When using this product

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

    Stop use and ask a doctor if

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

    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 (1-800-222-1222).

  • Directions

    •
    shake well before use
    •
    only use dose cup provided
    •
    adults and children 12 years and over:
    •
    15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
    •
    15 mL (1 dose) every ½ hour as needed overindulgence (upset stomach, heartburn, indigestion, nausea)
    •
    do not exceed 8 doses (120 mL) in 24 hours
    •
    use until diarrhea stops but not more than 2 days
    •
    children under 12 years: ask a doctor
    •
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • Other information

    •
    each 15 mL contains: sodium 10 mg
    •
    salicylate 230 mg
    •
    low sodium
    •
    sugar free
    •
    store at room temperature
    •
    protect from freezing
    •
    avoid excessive heat (over 104°F or 40°C)
  • Inactive ingredients

    carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

    Do not use if imprinted shrink band is missing or broken.

  • Principal Display Panel

    DRx Choice®

    NDC# 68163-707-12

    Compare to the active ingredient in Pepto-Bismol® Ultra Strength

    Ultra strength

    Pink bismuth

    Bismuth Subsalicylate /

    Upset Stomach Reliever/Antidiarrheal

    Original Flavor

    Naturally and Artificially Flavored

    Relieves:

    Nausea, Heartburn, Indigestion, Upset Stomach & Diarrhea

    12 FL. OZ. (354 mL)

    Manufactured by: Raritan Pharmaceuticals

    8 Joanna Court

    East Brunswick

    NJ 08816

    *This product is not manufactured or distributed by The Procter & Gamble Co., owner of the registered trademark Pepto-Bismol®.

    DRx Choice stomach relief Ultra Strength original flavor
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE STOMACH RELIEF  REGULAR STRENGTH
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-707
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (viscous) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-707-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product12/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33512/06/2021
    Labeler - RARITAN PHAMACEUTICALS INC (127602287)
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