Label: MEDIQUE DIAMODE- loperamide hydrochloride tablet

  • NDC Code(s): 47682-200-33, 47682-200-46, 47682-200-50, 47682-200-64, view more
    47682-200-69
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Loperamide HCl USP, 2mg

  • PURPOSE

    Purpose

    Anti-diarrheal

  • INDICATIONS & USAGE

    Uses

    Controls symptoms of diarrhea, including Travelers' Diarrhea.

  • WARNINGS

    Warnings

    Allery alert:

    Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

    Heart alert:

    Taking more than directed can cause serious heart problems or death.

    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
    • a history of abnormal heart rythm

    Ask a doctor or pharmacist before use if you are

    • taking a precription drug. Loperamide may interect with certain prescription drugs.

    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 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 the 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

    Adults and children (12 years and over): Take 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours.

    Children under 12 years: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • store between 68º - 77ºF (20º - 25ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packet
    • see back of packet for lot number and expiration date
  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow # 10 aluminum lake, FD&C Blue # 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

  • QUESTIONS

    Questions or comments?

    1-800-634-7680

  • Medique Diamode Label

    Medique ®

    Diamode

    Controls the Symptoms of Diarrhea

    Pull to Open

    This Package is for Households without Young Children.

    Antidiarrheal • Loperamide HCl 2 mg

    24 Caplets

    (24 x 1)

    Tamper Evident Unit Dose Packets

    Diamode

  • INGREDIENTS AND APPEARANCE
    MEDIQUE DIAMODE 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-200
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    Product Characteristics
    Colorgreen (Green) Score2 pieces
    ShapeOVAL (Caplet) Size10mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-200-696 in 1 BOX12/30/2008
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-200-5050 in 1 BOX12/30/200805/01/2023
    21 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-200-33100 in 1 BOX12/30/200805/01/2023
    31 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-200-461 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    5NDC:47682-200-6424 in 1 BOX08/14/2020
    51 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409112/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
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