Label: COLOCYNTHIS- colocynth granule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 27, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    COLOCYNTHIS 200K GR

    COLOCYNTHIS 30CH GR

    COLOCYNTHIS 30K GR

    COLOCYNTHIS 5CH GR

    COLOCYNTHIS 7CH GR

  • PURPOSE

    Indications

    For the temporary relief of cramps and pains

  • WARNINGS

    Warning:
    If pregnant or breastfeeding, 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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Lactose,
    sucrose.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • QUESTIONS

    QUESTIONS? 1-888-737-6925.

  • INDICATIONS & USAGE

    Indications

    For the temporary relief of cramps and pains

    Directions
    Adults: Take five granules three times daily or as recommended by your healthcare practitioner.
    Children: Take three granules and follow adult directions.

  • PRINCIPAL DISPLAY PANEL

    62106-7747

    UNDA
    Do not use if label perforation is broken
    Homeopathic Remedy
    NDC : 62106-7747-4
    COLOCYNTHIS
    Colocynth
    140 granules
    Indications

    For the temporary relief of cramps and pains

  • INGREDIENTS AND APPEARANCE
    COLOCYNTHIS 
    colocynth granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-7747
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-7747-410 in 1 CARTON04/07/201507/31/2024
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/07/201507/31/2024
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-7747)
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