Label: ANTI-DIARRHEAL, CIRCLE K- loperamide hcl tablet tablet

  • NDC Code(s): 66715-5529-2
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 12, 2022

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  • Drug Facts

  • Active ingredient (in each caplet)

    Loperamide HCl, USP 2 mg

    Purpose

    Anti-diarrheal

  • Use

    Controls symptoms of diarrhea, including Travelers’ Diarrhea

  • Warnings

    Allergy alert

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

    Heart alert

    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
    ■ 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 right away. (1-800-222-1222)

  • Directions

    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 hour

    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

    (up to 33 lbs)

    		do not use

  • Other information

    Other information

    ■ store between 68-77°F (20-25°C)

  • Inactive ingredients

    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 or comments?

    Questions or comments?
    call toll-free 1-877-507-6516 (M-F 8AM - 4:30PM CST)

  • PDP [Circle K Anti-Diarrheal, 2mg Loperamide]

    CONTROLS THE SYMPTOMS OF DIARRHEA
    Compare to the active ingredient in
    Imodium® A-D*

    CIRCLE K ™

    antidiarrheal
    Loperamide HCI
    Tablets, USP
    2 mg

    [caplet image]

    actual size

    4 caplets** (2 per pouch)

    PDP

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL, CIRCLE K 
    loperamide hcl tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5529
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-5529-22 in 1 CARTON03/26/2021
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409103/26/2021
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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