Label: PRIMULA SCILLA SPECIAL ORDER 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 August 3, 2017

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  • INDICATIONS & USAGE

    Directions: FOR ORAL USE.

  • DOSAGE & ADMINISTRATION

    Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

  • ACTIVE INGREDIENT

    Active Ingredients: Cactus (Queen of the night) 3X, Convallaria (Lily of the valley) 3X, Crataegus (Hawthorn) 3X, Melissa (Lemon balm) 3X, Onopordon (Cotton thistle) 3X, Primula (Cowslip)
    3X, Scilla (Sea onion) 3X, Hyoscyamus (Henbane) 4X, Cor (Bovine heart) 6X, Conchae (Oyster shells) 10X

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Salt

  • PURPOSE

    Use: Temporary relief of headache.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • WARNINGS

    Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use.

  • QUESTIONS

    Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

  • PRINCIPAL DISPLAY PANEL

    PrimulaScillaSpecialOrderAmpules

  • INGREDIENTS AND APPEARANCE
    PRIMULA SCILLA SPECIAL ORDER 
    primula scilla special order liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48951-8067
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM3 [hp_X]  in 1 mL
    CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE) CONVALLARIA MAJALIS3 [hp_X]  in 1 mL
    HAWTHORN LEAF WITH FLOWER (UNII: 6OM09RPY36) (HAWTHORN LEAF WITH FLOWER - UNII:6OM09RPY36) HAWTHORN LEAF WITH FLOWER3 [hp_X]  in 1 mL
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS3 [hp_X]  in 1 mL
    ONOPORDUM ACANTHIUM FLOWER (UNII: AP97AUF88E) (ONOPORDUM ACANTHIUM FLOWER - UNII:AP97AUF88E) ONOPORDUM ACANTHIUM FLOWER3 [hp_X]  in 1 mL
    PRIMULA VERIS FLOWER (UNII: W5BET37294) (PRIMULA VERIS FLOWER - UNII:W5BET37294) PRIMULA VERIS FLOWER3 [hp_X]  in 1 mL
    DRIMIA MARITIMA BULB (UNII: 3629601H5D) (DRIMIA MARITIMA BULB - UNII:3629601H5D) DRIMIA MARITIMA BULB3 [hp_X]  in 1 mL
    HYOSCYAMUS NIGER LEAF (UNII: 32IT7G8BAW) (HYOSCYAMUS NIGER LEAF - UNII:32IT7G8BAW) HYOSCYAMUS NIGER LEAF4 [hp_X]  in 1 mL
    BEEF HEART (UNII: P47W069U38) (BEEF HEART - UNII:P47W069U38) BEEF HEART6 [hp_X]  in 1 mL
    OSTREA EDULIS SHELL (UNII: 49OY13BE7Z) (OSTREA EDULIS SHELL - UNII:49OY13BE7Z) OSTREA EDULIS SHELL10 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48951-8067-110 in 1 BOX09/01/2009
    11 mL in 1 AMPULE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Uriel Pharmacy Inc. (043471163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uriel Pharmacy Inc.043471163manufacture(48951-8067)
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