UNDA 1000 (RUBUS FRUTICOSUS, SPONGIA TOSTA, CALENDULA OFFICINALIS, DROSERA) LIQUID [SEROYAL USA]

UNDA 1000 (RUBUS FRUTICOSUS, SPONGIA TOSTA, CALENDULA OFFICINALIS, DROSERA) LIQUID [SEROYAL USA]
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NDC 62106-1173-8
Set ID 206b66f0-67e1-5626-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Seroyal USA
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active ingredients
    Calendula officinalis (Marigold) Flowering Tops 4X
    Drosera (Sundew) Whole Plant 4X
    Rubus fruticosus Leaf 4X
    Spongia tosta (Roasted sponge) 4X

  • PURPOSE

    Uses

    For the temporary relief of minor digestive upset and tiredness.

  • 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.

  • 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.

  • STOP USE

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

  • 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.

  • 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 minor digestive upset and tiredness.

    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

    62106-1173

    NDC 62106-1173-8

    UNDA
    numbered compounds
    UNDA 1000
    Homeopathic Preparation

    For the temporary relief of minor

    digestive upset and tiredness.
    Contains 31% Alcohol
    0.7 fl oz (20 ml)

  • INGREDIENTS AND APPEARANCE
    UNDA 1000 
    rubus fruticosus, spongia tosta, calendula officinalis, drosera liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1173
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9) (RUBUS FRUTICOSUS LEAF - UNII:YQ2S06L8S9) RUBUS FRUTICOSUS LEAF4 [hp_X]  in 20 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP4 [hp_X]  in 20 mL
    DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG) DROSERA ROTUNDIFOLIA FLOWERING TOP4 [hp_X]  in 20 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED4 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1173-81 in 1 CARTON09/23/2015
    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 homeopathic09/23/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-1173)

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