Label: STOMACH RELIEF- bismuth subsalicylate capsule, liquid filled

  • NDC Code(s): 83059-0026-8
  • Packager: Shield Pharmaceuticals Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever and anti-diarrheal

  • Uses

    relieves:
    • travelers' diarrhea
    • diarrhea
    • upset stomach due to
    • overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

  • 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

    Do not use if you have
    • an ulcer
    • a bleeding problem
    • bloody or black stool

  • ASK DOCTOR

    Ask a doctor before use if you have
    • fever
    • mucus in the stool

  • ASK DOCTOR/PHARMACIST

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

    • any drug for
    • anticoagulation (thinning the blood)
    • diabetes 
    • gout
    • arthritis

  • WHEN USING

    When using this product
    • a temporary, but harmless, darkening of the stool and/or tongue may occur

  • STOP USE

    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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • Directions

    • swallow with water, do not chew
    • adults and children 12 years and over:
    • 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea
    • 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
    • do not exceed 8 doses (16 softgels) 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 softgel contains: salicylate 99 mg
    • very low sodium
    • store between 20-25° C (68-77° F)

  • Questions or comments?

    1-800-373-6981 (toll-free)

  • Inactive ingredients

    FD&C red #33, gelatin, glycerin, lecithin, polyethylene glycol-400, polysorbate 80, povidone, sorbitan, titanium dioxide

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Shield Pharmaceuticals Corp.
    Hauppauge, NY 11788

  • PRINCIPAL DISPLAY PANEL

    ValuRx

    Compare to the active ingredient in Pepto-Bismol® LiquicapsTM†

    Stomach Relief
    Bismuth Subsalicylate
    Upset Stomach Reliever/Antidiarrheal
    Soothing Relieves of 5 Symptoms:
    • Nausea
    • Heartburn
    • Indigestion
    • Upset Stomach
    • Diarrhea

    Carton

    Bismuth Carton

  • INGREDIENTS AND APPEARANCE
    STOMACH RELIEF 
    bismuth subsalicylate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83059-0026
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH (UNII: U015TT5I8H) (BISMUTH - UNII:U015TT5I8H) BISMUTH262 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code SD30
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83059-0026-81 in 1 CARTON04/07/2024
    18 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00804/07/2024
    Labeler - Shield Pharmaceuticals Corp (118724924)