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 11673-122-48
Set ID 7f6b2960-943d-464c-9ff9-4649a8ab4a4e
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 tablet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Anti-diarrheal/Upset stomach reliever

    Uses

    relieves

    •
    traveler’s 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 if you have

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

    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

    •
    chew or dissolve tablets in mouth
    •
    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 tablets contains: salicylate 102 mg
    •
    avoid excessive heat (over 104°F or 40°C)
  • Inactive ingredients

    Flavor, magnesium stearate, microcrystalline cellulose, red# 27 aluminum lake, sorbitol, sucralose.

  • PRINCIPAL DISPLAY PANEL

    NDC 11673-122-48

    Compare to active ingredient in Pepto-Bismol® Chewable Tablets*

    5- symptom digestive relief

    Bismuth subsalicylate, 262 mg/antidiarrheal

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

    48 TABLETS

    K PARAVE

    48 CHEWABLE TABLETS

    TAMPER EVIDENT: DO NOT USE IF INDIVIDUAL BLISTER COMPARTMENTS ARE TORN OR OPEN

    245 05 0378 R01 ID285492

    Dist.by Target Corp., Mpls, MN 55403

    ©2015 Target Brands, Inc.

    Shop Target.com

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

    up & up digestive relief bismuth subsalicylate
  • INGREDIENTS AND APPEARANCE
    UP AND UP 5-SYMPTOM DIGESTIVE RELIEF 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-122
    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
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code RP124
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-122-4848 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33503/12/2019
    Labeler - Target Corporation (006961700)
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