Label: UNDA 19- aluminium metallicum, drosera, illicium verum, mentha piperita, senega officinalis 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 December 18, 2019

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

  • ACTIVE INGREDIENT

    Active ingredients
    Each drop contains:
    Aluminium metallicum (Aluminum) 12X
    Drosera (Sundew) Whole Plant 5X
    Illicium verum (Star anise) Fruit 3X
    Mentha piperita Aerial Parts 5X
    Senega officinalis (Seneca snakeroot) Root 4X

  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with minor respiratory problems.

  • WARNINGS

    Warnings
    Ask a doctor before use if you have
    Persistent or chronic cough such as
    occurs with smoking, asthma, chronic
    bronchitis, or emphysema.
    Cough that is accompanied by
    excessive phlegm (mucus) or fever.

    Stop use and ask a doctor if
    Cough persists for more than 1 week,
    tends to recur, or is accompanied by a
    fever, rash, or persistent headache. A
    persistent cough may be a sign of a
    serious condition.
    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.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • ASK DOCTOR

    Ask a doctor before use if you have
    Persistent or chronic cough such as
    occurs with smoking, asthma, chronic
    bronchitis, or emphysema.
    Cough that is accompanied by
    excessive phlegm (mucus) or fever

  • STOP USE

    Stop use and ask a doctor if
    Cough persists for more than 1 week,
    tends to recur, or is accompanied by a
    fever, rash, or persistent headache. A
    persistent cough may be a sign of a
    serious condition.

    Symptoms persist or worsen.

  • 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

  • INACTIVE INGREDIENT

    Inactive ingredients
    Ethanol (beet), purified water

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and adolescents (12 years and older)
    Take 5 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 minor respiratory problems.

    Directions

    Adults and adolescents (12 years and older)
    Take 5 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

    62106-1118

    NDC 62106-1118-8

    UNDA

    numbered compounds

    UNDA 19

    Homeopathic Preparation

    For the temporary relief of symptoms

    associated with minor respiratory problems.

    Contains 32% Alcohol

    0.7 fl oz (20 mL)

  • INGREDIENTS AND APPEARANCE
    UNDA 19 
    aluminium metallicum, drosera, illicium verum, mentha piperita, senega officinalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM (UNII: CPD4NFA903) (ALUMINUM - UNII:CPD4NFA903) ALUMINUM12 [hp_X]  in 20 mL
    STAR ANISE FRUIT (UNII: CK15HA8438) (STAR ANISE FRUIT - UNII:CK15HA8438) STAR ANISE FRUIT3 [hp_X]  in 20 mL
    POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF) POLYGALA SENEGA ROOT4 [hp_X]  in 20 mL
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP5 [hp_X]  in 20 mL
    PEPPERMINT (UNII: V95R5KMY2B) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT5 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1118-81 in 1 CARTON04/03/2017
    120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/03/2017
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1118)