Label: LOPERAMIDE HYDROCHLORIDE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Loperamide Hydrochloride USP, 2 mg

  • Purpose

    Anti-diarrheal

  • Use

    controls symptoms of diarrhea, including Travelers' Diarrhea

  • Warnings

    Allergy alert

    Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride

    Heart alert

    Taking more than directed can cause serious heart problems or death

    Do not useif you have bloody or black stool

    Ask a doctor before use if you have

    • fever
    • mucus in the stool
    • a history of liver disease
    • a history of abnormal heart rhythm

    Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

    When using this producttiredness, 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 right away (1-800-222-1222).

  • 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 over2 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 2-5 years (34 to 47 lbs)ask a doctor
    children under 2 years (up to 33 lbs)do not use
  • Other information

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

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

  • Questions?

    Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

  • SPL UNCLASSIFIED SECTION

    Distributed by
    ZEE MEDICAL, INC.,Irvine, CA 92606

  • PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton

    COMPARE TO THE
    ACTIVE INGREDIENT IN
    IMODIUM ®A-D**

    ZEE ®

    Loperamide Hydrochloride
    Tablets USP, 2 mg

    Anti-Diarrheal

    See New Warnings
    and Directions

    12 Caplets*

    Each caplet (*capsule-shaped tablet)
    contains Loperamide Hydrochloride USP, 2 mg

    Controls the Symptoms
    of Diarrhea

    PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-123
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeCAPSULE (shaped tablet) Size9mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35418-123-122 in 1 CARTON01/16/2014
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409101/16/2014
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ranbaxy Pharmaceuticals Inc (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM LABORATORIES INC.051565745manufacture(35418-123)
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