Label: LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride tablet

  • NDC Code(s): 55315-123-06, 55315-123-24
  • Packager: Fred's Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/13

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

  • ACTIVE INGREDIENT (IN EACH CAPLET)

    Loperamide HCI USP, 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 reaction to loperamide HCI

    Do not use

    If you have bloody or black stool

    Ask a doctor before use if you have

    • 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

    • diarrhea lasts for more than 2 days
    • symptoms get worse
    • 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 right away (1-800-222-1222).

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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;
      ½ 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;
      ½ 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

    • store between 20° – 25° C (68° – 77° F)
    • see side panel for batch number and expiration date
    • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
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  • INACTIVE INGREDIENTS

    Anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

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  • QUESTIONS?

    Call 1800-406-7984

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  • PRINCIPAL DISPLAY PANEL

    fred's®

    Loperamide Hydrochloride Tablets USP, 2 mg

    Anti-Diarrheal

    Controls The Symptoms of Diarrhea

    24 CAPLETS*

    Each Caplet (*capsule-shaped tablet)

    contains Loperamide HCl USP, 2 mg

    Compare to Active Ingredient of Imodium®A-D

    DISTRIBUTED BY: fred's Inc.

    5091235/R1111

    This is the 24 count blister carton label for Fred's Loperamide HCl tablets USP, 2 mg.
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  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-123
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TRISTEARIN (UNII: P6OCJ2551R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color green Score 2 pieces
    Shape CAPSULE Size 9mm
    Flavor Imprint Code 123
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-123-06 6 in 1 BLISTER PACK
    2 NDC:55315-123-24 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074091 02/01/1993
    Labeler - Fred's Inc. (005866116)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 051565745 manufacture(55315-123)
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