Label: MEDIQUE DIAMODE- loperamide hydrochloride tablet

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

Drug Label Information

Updated March 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Loperamide HCl USP, 2mg

  • Purpose

    Anti-diarrheal

  • Uses

    Controls symptoms of diarrhea, including Travelers' Diarrhea.

  • 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

    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 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

    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: Do not give to children under 12 years of age.

  • 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 ingredients

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

  • Questions or comments?

    1-800-634-7680

  • Medique Diamode Label

    Diamode

    Controls the Symptoms of Diarrhea

    Pull to Open

    See New Warnings Information

    Antidiarrheal • Loperamide HCl 2 mg

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    71205-316-06
  • INGREDIENTS AND APPEARANCE
    MEDIQUE DIAMODE 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-316(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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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:71205-316-011 in 1 PACKET; Type 0: Not a Combination Product09/01/2019
    2NDC:71205-316-066 in 1 PACKET; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409112/30/2008
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-316) , RELABEL(71205-316)
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