Label: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE- loperamide hydrochloride and simethicone tablet

  • NDC Code(s): 69230-325-04, 69230-325-06, 69230-325-08, 69230-325-12, view more
    69230-325-18, 69230-325-24, 69230-325-31, 69230-325-32
  • Packager: Camber Consumer Care Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 21, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT(S)

    (in each tablet)
    Loperamide Hydrochloride USP 2 mg
    Simethicone USP 125 mg

  • PURPOSES

    Anti-diarrheal
    Anti-gas

  • USE(S)

    relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

  • 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 USE

    • if you have bloody or black stool
    • if you have difficulty swallowing

  • 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.
    • you have difficulty swallowing the tablet

  • PREGNANCY OR BREAST FEEDING

    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
    • take only on an empty stomach (1 hour before or 2 hours after a meal)
    • take with a full (8 oz.) glass of water
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.



    adults and children 12 years and over
    2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours

    children 9-11 years
    (60-95 lbs)
    1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours

    children 6-8 years

    (48-59 lbs)

    1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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

     each tablet contains: calcium 640 mg, very low sodium and potassium 5.838 mg
    • store between 20 to 25°C (68 to 77°F). Protect from light.
    • do not use if carton is open or if blister unit is open or torn

  • INACTIVE INGREDIENTS

    acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor

  • QUESTIONS OR COMMENTS

    call 1-888-588-1418

    Distributed by:

    Camber Consumer Care, Inc.

    Piscataway, NJ 08854, USA.

  • PRINCIPAL DISPLAY PANEL

    Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton


    6scarton

  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE  
    loperamide hydrochloride and simethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULESize17mm
    FlavorVANILLAImprint Code H;L21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-325-041 in 1 CARTON06/17/2021
    1NDC:69230-325-314 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69230-325-082 in 1 CARTON06/17/2021
    2NDC:69230-325-314 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:69230-325-061 in 1 CARTON06/17/2021
    3NDC:69230-325-326 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:69230-325-122 in 1 CARTON06/17/2021
    4NDC:69230-325-326 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:69230-325-183 in 1 CARTON06/17/2021
    5NDC:69230-325-326 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:69230-325-244 in 1 CARTON06/17/2021
    6NDC:69230-325-326 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21143806/17/2021
    Labeler - Camber Consumer Care Inc (079539968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Annora Pharma Private Limited650980746analysis(69230-325) , manufacture(69230-325)