Label: EPIPHANIQ- zincum iodatum solution

  • 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 29, 2021

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  • ACTIVE INGREDIENT

    ZINCUM IODATUM 2X HPUS

  • PURPOSE

    TO TREAT RESPIRATORY DIFFICULTIES, COUGH AND PERTUSSIS

  • USES

    Relieves respiratory difficulties and bronchial irritations (cough).

  • WARNINGS

    • If pregnant or breast-feeding ask a healthcare professional before use
    • Children under 12: consult a doctor before use
    • Do not exceed recommended dosage
    • The use of this container by more than one person may spread infection
    • For your safety do not use if seal is broken
  • 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
  • DIRECTIONS

    Oral Liquid:

    Shake well before use.

    Mix liquid as detailed below into a glass of water or juice.

    • Adults and children 13 years and older (up to 120lbs): 5ml, three times daily
    • For heavier body weight or very severe cases dose 10ml, three times daily

    Sachet:

    Pour contents of sachets into a glass of water or juice as detailed below

    • Adults and children 13 years and older (up to 120lbs): 1 sachet, three times daily
    • For heavier body weight or very severe cases dose 2 sachets, three times daily
  • INACTIVE INGREDIENTS

    DMSO, WATER

  • QUESTIONS

    CALL TOLL FREE 1-800-XXX-XXXX IN THE U.S., 24 HRS, 7 DAY/WEEK

  • PRINCIPAL DISPLAY PANEL

    01b LBL_EpiphaniQ_Oral solution_front

    01b LBL_EpiphaniQ_Oral solution_back

    01b UC_EpiphaniQ_Oral Liquid_Sachet_50ct

  • INGREDIENTS AND APPEARANCE
    EPIPHANIQ 
    zincum iodatum solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79813-204
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC IODIDE (UNII: 762R7A0O0B) (ZINC IODIDE - UNII:762R7A0O0B) ZINC IODIDE2 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79813-204-511 in 1 CARTON07/23/2020
    1NDC:79813-204-11100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:79813-204-5250 in 1 CARTON07/23/2020
    2NDC:79813-204-215 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/23/2020
    Labeler - EpiphaniQ LLC (117591249)
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