Label: SINUTONE (echinacea (angustifolia), hydrastis canadensis, allium cepa, ambrosia artemisiaefolia, arsenicum album, kali bichromicum, nux moschata, pulsatilla- pratensis, sepia, solidago virgaurea 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 April 19, 2024

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  • ACTIVE INGREDIENTS:

    (in each drop): 11.10% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Hydrastis Canadensis 6X, Kali Bichromicum 12X, Nux Moschata 12X, Pulsatilla (Pratensis) 12X, Sepia 12X, Solidago Virgaurea 12X; 0.10% of Echinacea (Angustifolia) 3X.

  • INDICATIONS:

    May temporarily relieve allergic rhinitis with runny nose, nasal mucus with yellow green discharge, pain and swelling of sinus cavities, and postnasal drip.**

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

  • WARNINGS:

    If pregnant or breast-feeding, 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.

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

  • 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:

    Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve allergic rhinitis with runny nose, nasal mucus with yellow green discharge, pain and swelling of sinus cavities, and postnasal drip.**

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

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol.

  • QUESTIONS:

    Dist. by Energique, Inc.

    201 Apple Blvd.
    Woodbine, IA 51579 800-869-8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    HOMEOPATHIC REMEDY

    SINUTONE

    1 fl. oz. (30 ml)

    Sinutone

  • INGREDIENTS AND APPEARANCE
    SINUTONE 
    echinacea (angustifolia), hydrastis canadensis, allium cepa, ambrosia artemisiaefolia, arsenicum album, kali bichromicum, nux moschata, pulsatilla (pratensis), sepia, solidago virgaurea liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0515
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION12 [hp_X]  in 1 mL
    AMBROSIA ARTEMISIIFOLIA WHOLE (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA WHOLE12 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE12 [hp_X]  in 1 mL
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG12 [hp_X]  in 1 mL
    PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0515-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/09/2019
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0515) , api manufacture(44911-0515) , label(44911-0515) , pack(44911-0515)
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