UP AND UP 5-SYMPTOM DIGESTIVE RELIEF (BISMUTH SUBSALICYLATE) TABLET [TARGET CORPORATION]

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UP AND UP 5-SYMPTOM DIGESTIVE RELIEF (BISMUTH SUBSALICYLATE) TABLET [TARGET CORPORATION]
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NDC 11673-125-20
Set ID 6462e224-5ee7-4556-90f2-994eaf89b71b
Category HUMAN OTC DRUG LABEL
Packager Target Corporation
Generic Name
Product Class
Product Number
Application Number PART335
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever and anti-diarrheal

    Uses

    relieves

    ▪
    heartburn
    ▪
    indigestion
    ▪
    nausea
    ▪
    upset stomach
    ▪
    diarrhea
  • 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
    ▪
    bloody or black stool

    Ask a doctor before use if you have

    ▪
    fever
    ▪
    mucus in the stool

    Ask a doctor 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.

    Stop use and ask a doctor if

    ▪
    symptoms get worse or last more than 2 days
    ▪
    ringing in the ears occurs 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 immediately.1-800-222-1222.

  • Directions

    ▪
    swallow with water, do not chew
    ▪
    adults and children 12 years and older: 2 caplets every 1/2 to 1 hour as needed
    ▪
    do not exceed 8 doses (16 caplets) 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 caplet contains: calcium 27 mg
    ▪
    sodium 3 mg
    ▪
    salicylate 99 mg
    ▪
    low sodium
    ▪
    sugar free
    ▪
    avoid excessive heat (over 104°F or 40°C)
  • Inactive ingredients

    calcium carbonate, crospovidone, D&C red#27 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate.

  • PRINCIPAL DISPLAY PANEL -

    NDC 11673-125-20

    Compare to active ingredient in Pepto-Bismol® Caplets*

    5- symptom digestive relief

    relief of upset stomach, nausea, heartburn, indigestion, diarrhea

    40 CAPLETS

    *This product is not manufactured or distributed by Procter & Gamble Inc. the distributor of PEPTO-BISMOL®

    TAMPER EVIDENT DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

    245 05 0375 R01 ID285492

    Dist.by Target Corp., Mpls ., MN 55403

    ©2017 Target Brands, Inc.

    Shop Target.com

    Guest Services 1-800-910-6874

    up and up 5-symptom digestive relief bismuth subsalicylate,262 mg/antidiarrheal Caplet
  • INGREDIENTS AND APPEARANCE
    UP AND UP 5-SYMPTOM DIGESTIVE RELIEF 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-125
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    calcium carbonate (UNII: H0G9379FGK)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorPINK (mottled light pink) Scoreno score
    ShapeOVAL (Oblong Caplet) Size16mm
    FlavorImprint Code RP125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-125-2040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33509/07/2015
    Labeler - Target Corporation (006961700)
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