Label: PANCREATINUM (oryctolagus cuniculus- rabbit pancreatin liquid

  • 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 November 7, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Formula

    Each Drop Contains: Oryctolagus cuniculus (Rabbit) Pancreatin 4CH

  • PURPOSE

    Indications

    For the temporary relief of symptoms
    associated with gastrointestinal
    discomforts.

  • WARNINGS

    Warnings
    If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. If symptoms persist or worsen, consult your healthcare practitioner.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • OVERDOSAGE

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

  • OTHER SAFETY INFORMATION

    Do not use if seal is missing or broken. Store in a cool, dry place.

  • INACTIVE INGREDIENT

    Inactive ingredients: Ethanol (beet), purified water

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and Children (over 12 years): Take 10 drops two to three times daily.*
    Children (1-12 years): Take three to five drops two to three times daily.*
    *Take for three weeks, then one week off and three weeks on for three months or as recommended by your healthcare practitioner. Evaluate after three months.

  • INDICATIONS & USAGE

    Indications

    For the temporary relief of symptoms associated with gastrointestinal discomforts.

    Directions
    Adults and Children (over 12 years): Take 10 drops two to three times daily.*
    Children (1-12 years): Take three to five drops two to three times daily.*
    *Take for three weeks, then one week off and three weeks on for three months or as recommended by your healthcare practitioner. Evaluate after three months.

  • PRINCIPAL DISPLAY PANEL

    62106-0287

    UNDA

    NDC 62106-0287-0

    PANCREATINUM

    4CH

    Homeopathic Remedy

    Contians 30% Alcohol

    1 fl oz (30 ml)

  • INGREDIENTS AND APPEARANCE
    PANCREATINUM 
    oryctolagus cuniculus (rabbit) pancreatin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-0287
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ORYCTOLAGUS CUNICULUS PANCREATIN (UNII: 34QK0IZ9HO) (ORYCTOLAGUS CUNICULUS PANCREATIN - UNII:34QK0IZ9HO) ORYCTOLAGUS CUNICULUS PANCREATIN4 [hp_C]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-0287-030 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/18/2018
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-0287)