Label: ANTI-DIARRHEAL- loperamide hydrochloride tablet

  • NDC Code(s): 21130-375-08
  • Packager: Better Living Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/15

If you are a consumer or patient please visit this version.

  • Active ingredient (in each caplet)

    Loperamide HCl 2 mg

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  • Purpose

    Anti-diarrheal

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  • Use

    controls symptoms of diarrhea, including Travelers' Diarrhea

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  • Warnings

    Allergy alert: Do not use if you have ever had a rash or other allergic reactions to loperamide HCl.

    Do not use

     if you have bloody or black stool.

    Ask a doctor before use if you have

    • a fever
    • mucus in the stool
    • a history of liver disease

    Ask a doctor or pharmacist before use if you are

    taking antibiotics.

    When using this product,

    tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

    Stop use and ask a doctor if

    • symptoms get worse
    • diarrhea lasts for more than 2 days
    • you get abdominal swelling or bulging. These may be signs of a serious condition.

    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 (1-800-222-1222) right away.

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  • Directions

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • find right dose on chart. If possible, use weight to dose; otherwise, use age.
    adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
    children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
    children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
    children under 6 years (up to 47 lbs) ask a doctor

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  • Other information

    • do not use if carton or blister unit is open or torn
    • store between 20º-25ºC (68º-77ºF)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    corn starch, D&C yellow # 10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

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  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

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  • Principal Display Panel

    Signature
    care

    Quality
    Guaranteed

    COMPARE TO
    Imodium® A-D
    active ingredient* 

    NDC 21130-375-08

    Anti-Diarrheal

    Loperamide HCl 2 mg
    Anti-Diarrheal

    Controls the symptoms
    of diarrhea

    Actual Size

    24 CAPLETS

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Imodium® A-D.
    50844        REV1212K37508

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    DISTRIBUTED BY
    BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929
    www.betterlivingbrandsLLC.com

    OUR PROMISE
    QUALITY & SATISFACTION
    100% GUARANTEED

    OR YOUR MONEY BACK.

    Signature Care 44-375

    Signature Care 44-375

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  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-375
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color GREEN Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code 44;375
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-375-08 4 in 1 CARTON
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076497 05/03/2005
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(21130-375)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(21130-375)
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