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

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 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 LABEL Item Code (Source) NDC:55315-123
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    CROSCARMELLOSE SODIUM  
    CROSPOVIDONE  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    TRISTEARIN  
    MAGNESIUM STEARATE  
    POWDERED CELLULOSE  
    STARCH, PREGELATINIZED CORN  
    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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