Label: KALIUM CARBONICUM PLEX- asafoetida, carbo vegetabilis, cinchona succirubra, kali carbonicum, lycopodium clavatum, nux moschata, nux vomica, raphanus sativus var niger liquid

  • Category: HUMAN OTC DRUG LABEL

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 9, 2022

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  • ACTIVE INGREDIENT

    Active ingredients

    Each drop contains:

    Asafoetida (Devil's dung) Gum Resin 6X
    Carbo vegetabilis (Vegetable charcoal) 6X
    Cinchona succirubra (Cinchona) Bark 6X
    Kali carbonicum (Potassium carbonate) 6X
    Lycopodium clavatum (Clubmoss) Spores 6X
    Nux moschata (Nutmeg) Seeds 6X
    Nux vomica (Poison nut) Seeds 6X (<2.7 x 10-7 % alkaloids, calculated)
    Raphanus sativus var niger (Black radish) Underground Parts 6X

  • PURPOSE

    Uses

    For the temporary relief of symptoms associated with digestive upset such as:
    Bloating

    Indigestion

    Colic

  • WARNINGS

    Warnings
    Stop use and ask a doctor if symptoms persist or worsen.
    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.

  • STOP USE

    Stop use and ask a doctor if symptoms persist or worsen.

  • 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
    Ethanol (beet), purified water

  • OTHER SAFETY INFORMATION

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

    Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity

  • DOSAGE & ADMINISTRATION

    Directions
    To be taken ten minutes away from food.
    Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
    Hold contents for about 20 seconds and swallow.
    To promote drop flow, invert bottle and shake before each use.
    Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

    Adults and adolescents (12 years and older)

    Take 10 drops three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of symptoms associated with digestive upset such as:
    Bloating

    Indigestion

    Colic

    Directions
    To be taken ten minutes away from food.
    Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
    Hold contents for about 20 seconds and swallow.
    To promote drop flow, invert bottle and shake before each use.
    Dosage frequency may be increased up to six times daily depending on the severity of symptoms.

    Adults and adolescents (12 years and older)

    Take 10 drops three times daily or as recommended by your healthcare practitioner.

    Children (under 12 years)

    Take under the direction of your healthcare practitioner.

  • PRINCIPAL DISPLAY PANEL

    62106-1202

    NDC 62106-1202-0

    UNDA

    plex

    KALIUM CARBONICUM PLEX

    Homeopathic Preparation

    For the temporary relief of symptoms associated with digestive upset.

    Contains 70% Alcohol
    1 fl oz (30 mL)

  • INGREDIENTS AND APPEARANCE
    KALIUM CARBONICUM PLEX 
    asafoetida, carbo vegetabilis, cinchona succirubra, kali carbonicum, lycopodium clavatum, nux moschata, nux vomica, raphanus sativus var niger liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1202
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA6 [hp_X]  in 30 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL6 [hp_X]  in 30 mL
    CINCHONA PUBESCENS BARK (UNII: S96N10R972) (CINCHONA PUBESCENS BARK - UNII:S96N10R972) CINCHONA PUBESCENS BARK6 [hp_X]  in 30 mL
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG6 [hp_X]  in 30 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE6 [hp_X]  in 30 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE6 [hp_X]  in 30 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]  in 30 mL
    RAPHANUS SATIVUS (UNII: 86R5J6D01D) (RAPHANUS SATIVUS - UNII:86R5J6D01D) RAPHANUS SATIVUS6 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1202-01 in 1 CARTON12/16/2015
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/16/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-1202)
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