Label: GUNA SINUS PLUS- althaea officinalis leaf - calcium sulfide - copper - drimia maritima bulb - echinacea angustifolia - hydrastis canadensis whole - lobaria pulmonaria - manganese - mercuric sulfide - onion - plantago major whole - potassium dichromate - pulsatilla vulgaris - silicon dioxide - silver nitrate - sinusitisinum - sus scrofa nasal mucosa - spray

  • Category: HUMAN OTC DRUG LABEL

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 February 17, 2021

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  • DIRECTIONS

    Adults and children 12 years and older 2 sprays to each nostril, 3-5 times per day



    Children between 12 years and 6 years of age 1 spray to each nostril, 3-5 times per day



    Children under 6 years consult a physician



  • ACTIVE INGREDIENTS/PURPOSE

    • ALLIUM CEPA 6X, 8X, 12X Relieves hay fever
    • ALTHEA OFFICINALIS 2X Soothing
    • ARGENTUM NITRICUM 10X Relieves cold symptoms
    • ASCORBIC ACIDUM 3X Relieves cold symptoms
    • ECHINACEA 3X Relieves cold symptoms
    • HEPAR SULPHURIS CALCAREUM 6X, 8X, 12X Relieves hay fever
    • HYDRASTIS CANADENSIS 6X, 8X, 12X Relieves mucus buildup
    • KALI BICHROMICUM 6X, 8X, 12X Relieves mucus buildup
    • MERCURIUS SOLUBILIS 8X Relieves mucus buildup
    • MUCOSA NASALIS SUIS 6X, 12X, 30X Relieves stuffy nose
    • PLANTAGO MAJOR 2X Relieves sinus headache
    • PULSATILLA 6X, 8X, 12X Relieves sinus headache
    • SCILLA MARITIMA 12X Relieves nasal discharge
    • SILICEA 6X, 8X, 12X Relieves runny nose
    • SINUSITISINUM 12X, 30X Relieves nasal congestion
    • STICTA PULMONARIA 2X Relieves rhinitis
    • CUPRUM METALLICUM 8X Supports respiratory organs
    • MANGANUM METALLICUM 8X Supports respiratory organs
  • INDICATIONS & USAGE

    Directions:

    tilt head forward slightly, insert the canister tip in the nose, aiming the tip toward the back of the head. Squeeze the pump and spray intro nostril.

  • INACTIVE INGREDIENT

    Inactive ingredient:purified water, potassium sorbate, sodium benzoate.

  • QUESTIONS

    Questions?: info@gunainc.com

    Tel. (484) 223-3500


  • WARNINGS

    Keep out of reach of children.

  • PREGNANCY

    If pregnant or breast-feeding ask a health care profesisonal before use

  • WARNINGS

    • Stop use and ask doctor if symptoms persist more than 5 days.
    • If pregnant or breast-feeding ask a health professional before use.
    • Keep out of reach of children. In case of overdose, seek professional assistance or contact a Poison Control Center immediately.
  • USES

    Relieves symptoms of rhinitis and sinusitis such as:

    • runny nose
    • headache
    • mucus buildup
    • nasal congestion



  • PRINCIPAL DISPLAY PANEL

    5USSIP-4

  • INGREDIENTS AND APPEARANCE
    GUNA SINUS PLUS 
    althaea officinalis leaf - calcium sulfide - copper - drimia maritima bulb - echinacea angustifolia - hydrastis canadensis whole - lobaria pulmonaria - manganese - mercuric sulfide - onion - plantago major whole - potassium dichromate - pulsatilla vulgaris - silicon dioxide - silver nitrate - sinusitisinum - sus scrofa nasal mucosa - spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-472
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 30 mL
    ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338) (ALTHAEA OFFICINALIS LEAF - UNII:E2QQV92338) ALTHAEA OFFICINALIS LEAF2 [hp_X]  in 30 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]  in 30 mL
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID3 [hp_X]  in 30 mL
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T) HYDRASTIS CANADENSIS WHOLE6 [hp_X]  in 30 mL
    LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA2 [hp_X]  in 30 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER8 [hp_X]  in 30 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 30 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_X]  in 30 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_X]  in 30 mL
    MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P) MANGANESE8 [hp_X]  in 30 mL
    MERCURIC SULFIDE (UNII: ZI0T668SF1) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC SULFIDE8 [hp_X]  in 30 mL
    SUS SCROFA NASAL MUCOSA (UNII: ID3Z1X61WY) (SUS SCROFA NASAL MUCOSA - UNII:ID3Z1X61WY) SUS SCROFA NASAL MUCOSA6 [hp_X]  in 30 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]  in 30 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 [hp_X]  in 30 mL
    SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5) SINUSITISINUM12 [hp_X]  in 30 mL
    PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR WHOLE - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE2 [hp_X]  in 30 mL
    DRIMIA MARITIMA BULB (UNII: 3629601H5D) (DRIMIA MARITIMA BULB - UNII:3629601H5D) DRIMIA MARITIMA BULB12 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.03 mL  in 30 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.03 mL  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-472-231 in 1 BOX02/17/2021
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/17/2021
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-472)
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