Label: HYTEN FORMULA (allium sativum, kidney- bovine, leonurus cardiaca, viscum album, aurum metallicum, digitalis purpurea, glonoinum, lycopodium clavatum, rauwolfia serpentina, sulphur, plumbum aceticum, baryta muriatica spray

  • NDC Code(s): 83027-0108-1
  • Packager: Nutritional Specialties, Inc.
  • 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 September 28, 2023

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  • ACTIVE INGREDIENTS:

    Allium Sativum 6X, Kidney 6X, Leonurus Cardiaca 6X, Viscum Album 6X, Aurum Metallicum 12X, Digitalis Purpurea 12X, Glonoinum 12X, Lycopodium Clavatum 12X, Rauwolfia Serpentina 12X, Sulphur 12X, Plumbum Aceticum 12X, 30X, Baryta Muriatica 30X.

  • PURPOSE:

    Aids in temporary relief of headaches, frequent nosebleeds, excess water retention, nausea and dizziness.†

    †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    Professional Use Only

    If pregnant or breast-feeding, ask a health professional before use.

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

    If condition worsens, seek medical attention.

    KEEP OUT OF REACH OF CHILDREN

    Do not use if tamper evident seal is broken or missing.

    Store in a cool place after opening

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

  • INDICATIONS

    Aids in temporary relief of headaches, frequent nosebleeds, excess water retention, nausea and dizziness.†

    †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Alcohol USP 20%, Purified Water USP.

  • QUESTIONS:

    MANUFACTURED EXCLUSIVELY FOR

    NUTRITIONAL SPECIALTIES, INC.

    PO BOX 97227

    PITTSBURG, PA 15229

    www.phpltd.com

  • PACKAGE LABEL DISPLAY:

    Professional

    Health Products

    HOMEOPATHIC

    NDC 83027-0108-1

    HYTEN

    FORMULA

    2 FL. OZ (60 ml)

    HYTEN FORMULA

  • INGREDIENTS AND APPEARANCE
    HYTEN FORMULA 
    allium sativum, kidney (bovine), leonurus cardiaca, viscum album, aurum metallicum, digitalis purpurea, glonoinum, lycopodium clavatum, rauwolfia serpentina, sulphur, plumbum aceticum, baryta muriatica spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC6 [hp_X]  in 1 mL
    BEEF KIDNEY (UNII: 5HOC10FSIC) (BEEF KIDNEY - UNII:5HOC10FSIC) BEEF KIDNEY6 [hp_X]  in 1 mL
    LEONURUS CARDIACA WHOLE (UNII: 8NC0C2YXK0) (LEONURUS CARDIACA - UNII:8NC0C2YXK0) LEONURUS CARDIACA WHOLE6 [hp_X]  in 1 mL
    VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP6 [hp_X]  in 1 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD12 [hp_X]  in 1 mL
    DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B) DIGITALIS12 [hp_X]  in 1 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    RAUWOLFIA SERPENTINA (UNII: H192N84N1G) (RAUWOLFIA SERPENTINA - UNII:H192N84N1G) RAUWOLFIA SERPENTINA12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    LEAD ACETATE ANHYDROUS (UNII: KL498O6790) (LEAD IODIDE - UNII:OTL90F2GLT) LEAD ACETATE ANHYDROUS12 [hp_X]  in 1 mL
    BARIUM CHLORIDE DIHYDRATE (UNII: EL5GJ3U77E) (BARIUM CATION - UNII:V645272HLN) BARIUM CHLORIDE DIHYDRATE30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83027-0108-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/28/2023
    Labeler - Nutritional Specialties, Inc. (032744609)
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