DROSERA PLEX (COUGH SYRUP) SYRUP [SEROYAL USA]

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DROSERA PLEX (COUGH SYRUP) SYRUP [SEROYAL USA]
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NDC 62106-3126-1
Set ID 588871b1-1dae-3053-e053-2a91aa0a8124
Category HUMAN OTC DRUG LABEL
Packager Seroyal USA
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    Active ingredients
    Each tablespoon/teaspoon contains:
    Drosera (Sundew) Whole Plant 3X
    Hyoscyamus niger (Henbane) Whole Plant 10X
    Ipecacuanha (Ipecac) Underground Parts 6X
    Lachesis mutus (Bushmaster) Venom 10X
    Origanum vulgare (Wild marjoram) Aerial Parts 7X
    Papaver rhoeas (Corn poppy) Flower 5X
    Pulsatilla (Wind flower) Whole Plant 8X
    Rumex crispus (Curly dock) Underground Parts 10X
    Spongia tosta (Roasted sponge) 10X
    Sulphur (Sublimed sulphur) 8X

  • PURPOSE

    Uses
    For temporary cough relief.

  • 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.

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

  • DOSAGE & ADMINISTRATION

    Directions
    Adults

    Take 1 tablespoon (15 ml) three to five times daily, or as recommended by your healthcare practitioner.

    Children (over 2 years)

    Take 1 teaspoon (5 ml) three to five times daily, or as recommended by your healthcare practitioner.
    Children (under 2 years)

    Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses
    For temporary cough relief.

    Directions
    Adults

    Take 1 tablespoon (15 ml) three to five times daily, or as recommended by your healthcare practitioner.

    Children (over 2 years)

    Take 1 teaspoon (5 ml) three to five times daily, or as recommended by your healthcare practitioner.
    Children (under 2 years)

    Take under the direction of your healthcare practitioner.

  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    Caramel, ethanol, grape skin extract, hyssop aerial parts extract, maidenhair fern leaf extract, purified water, sucrose

  • PRINCIPAL DISPLAY PANEL

    62106-3126-1NDC 62106-3126-1

    UNDA

    plex

    DROSERA PLEX COUGH SYRUP

    Homeopathic preparation

    for temporary cough relief.

    Contains 5.5% Alcohol

    6.1 fl oz (180 ml)

  • INGREDIENTS AND APPEARANCE
    DROSERA PLEX 
    cough syrup syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-3126
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS8 [hp_X]  in 180 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED10 [hp_X]  in 180 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER10 [hp_X]  in 180 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]  in 180 mL
    PAPAVER RHOEAS FLOWER (UNII: Y1MLS7E68X) (PAPAVER RHOEAS FLOWER - UNII:Y1MLS7E68X) PAPAVER RHOEAS FLOWER5 [hp_X]  in 180 mL
    DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA3 [hp_X]  in 180 mL
    OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ) (OREGANO FLOWERING TOP - UNII:7K91ZBK8GJ) OREGANO FLOWERING TOP7 [hp_X]  in 180 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 [hp_X]  in 180 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC6 [hp_X]  in 180 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT10 [hp_X]  in 180 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    VITIS VINIFERA ANTHOCYANINS (UNII: F02KPB2508)  
    ADIANTUM CAPILLUS-VENERIS LEAF (UNII: 4817H7M565)  
    SUCROSE (UNII: C151H8M554)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-3126-11 in 1 CARTON09/06/2017
    1180 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/06/2017
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-3126)
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