Label: ACUSINE- hydrastis canadensis, lycopodium clavatum, ephedra vulgaris, mezereum, petroleum, pulsatilla, thuja occidentalis spray

  • NDC Code(s): 60986-1040-5, 60986-1040-6
  • Packager: Marco Pharma International LLC
  • 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 6, 2023

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  • ACTIVE INGREDIENT

    Hydrastis Canadensis 4xHPUS

    Lycopodium Clavatum 3xHPUS

    Ephedra Vulgaris 3xHPUS

    Mezereum 3xHPUS

    Petroleum 8xHPUS

    Pulsatilla 3xHPUS

    Thuja Occidentalis 10xHPUS

    The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States.

  • PURPOSE

    For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitis, and nasal dryness.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.

  • WARNINGS

    Do not spray in eyes, mouth or ears.

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

    If swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    (Read INDICATIONS & USAGE SECTION)

  • INACTIVE INGREDIENT

    Aqua Demineralisata; Aqua Hamamelidis; Alcohol 7.7% by volume, Glycerin and Thymol.

  • PRINCIPAL DISPLAY PANEL

    N1A213

  • INGREDIENTS AND APPEARANCE
    ACUSINE 
    hydrastis canadensis, lycopodium clavatum, ephedra vulgaris, mezereum, petroleum, pulsatilla, thuja occidentalis spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60986-1040
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE3 [hp_X]  in 1 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS3 [hp_X]  in 1 mL
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK3 [hp_X]  in 1 mL
    KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE8 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]  in 1 mL
    EPHEDRA DISTACHYA FLOWERING TWIG (UNII: R55VQ87DP3) (EPHEDRA DISTACHYA FLOWERING TWIG - UNII:R55VQ87DP3) EPHEDRA DISTACHYA FLOWERING TWIG3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL4 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    THYMOL (UNII: 3J50XA376E)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60986-1040-520 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/24/2021
    2NDC:60986-1040-615 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/24/2021
    Labeler - Marco Pharma International LLC (161994277)
    Registrant - Marco Pharma International LLC (161994277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nestmann Pharma GmbH323426262manufacture(60986-1040)
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