Label: ALLIUM CEPA PLEX- allium cepa, belladonna, euphrasia officinalis, hydrastis canadensis, kali bichromicum, mercurius dulcis, sambucus nigra 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 July 14, 2021

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  • ACTIVE INGREDIENT

    Active ingredients

    Each drop contains:

    Allium cepa (Onion) Bulb 6X
    Belladonna (Deadly nightshade) Whole Plant 6X (<1.43 x 10-8 % alkaloids, calculated)
    Euphrasia officinalis (Eyebright) Whole Plant 6X
    Hydrastis canadensis (Golden seal) Underground Parts 6X
    Kali bichromicum (Potassium bichromate) 6X
    Mercurius dulcis (Calomel) 6X
    Sambucus nigra (European elder) Leaves and Inflorescences 6X

  • PURPOSE

    Uses

    For the temporary relief of nasal congestion and watery eyes due to colds and allergies.

  • 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 nasal congestion and watery eyes due to colds and allergies.

    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

    Allium Cepa Plex

    NDC 62106-1192-0

    UNDA

    plex

    ALLIUM CEPA PLEX

    Homeopathic Preparation

    For the temporary relief of nasal congestion

    and watery eyes due to colds and allergies.

    Contains 30% Alcohol
    1 fl oz (30 mL)

  • INGREDIENTS AND APPEARANCE
    ALLIUM CEPA PLEX 
    allium cepa, belladonna, euphrasia officinalis, hydrastis canadensis, kali bichromicum, mercurius dulcis, sambucus nigra liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1192
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 30 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 30 mL
    ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE6 [hp_X]  in 30 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 30 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_X]  in 30 mL
    CALOMEL (UNII: J2D46N657D) (CALOMEL - UNII:J2D46N657D) CALOMEL6 [hp_X]  in 30 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP6 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1192-01 in 1 CARTON12/15/2015
    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 homeopathic12/15/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-1192)
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