Label: ANTI-DIARRHEAL- loperamide hcl tablet

  • NDC Code(s): 68016-301-06, 68016-301-18, 68016-301-24
  • Packager: Chain Drug Consortium
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 11, 2023

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  • Active ingredient (in each caplet)

    Loperamide HCl 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 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 rhythm

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Loperamide may interact 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 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 (1-800-222-1222) right away.

  • 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; 1/2 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; 1/2 caplet after each subsequent
    loose stool; but no more than 2 caplets in 24 hours
    children 2-5 years (34-47 lbs)ask a doctor
    children under 2 years (up to 33 lbs) do not use

  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store between 20°-25°C (68°-77°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

  • Principal Display Panel

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

    Premier
    Value®

    Anti-diarrheal
    Loperamide HCl Tablets, 2 mg
    ANTI-DIARRHEAL

    Controls the symptoms
    of diarrhea

    6 Caplets

    actual size

    TAMPER EVIDENT: DO NOT USE IF PACKAGE
    IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS
    ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Johnson &
    Johnson Corporation, owner of the registered trademark Imodium® A-D.

    50844 ORG061937545

    Distributed by:
    Pharmacy Value Alliance, LLC
    407 East Lancaster Avenue, Wayne, PA 19087


    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED
    If for any reason you are not satisfied with
    this product, please return it to the store
    where purchased for a full refund.

    Premier Value 44-375

    Premier Value 44-375

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-301
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 44;375
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-301-061 in 1 CARTON12/06/2019
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:68016-301-183 in 1 CARTON12/06/2019
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:68016-301-244 in 1 CARTON12/06/2019
    36 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07649712/06/2019
    Labeler - Chain Drug Consortium (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(68016-301) , pack(68016-301)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(68016-301)
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