Label: SINUS RELIEF- natural medicine 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 October 21, 2011

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  • OTC Active Ingredient

    HPUS active ingredients

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies

    Apis mellifica

    Baptisia tinctoria

    Colocynthis

    Hepar sulphuris calcareum

    Histaminum hydrochloricum

    Hydrastis canadensis

    Ignatia amara

    Kali bichromicum

    Lemna minor

    Mercurius vivus

    Pulsatilla

    Rhus toxicodendron

    Sabadilla

    Thuja occidentalis

    Reference image sinus.jpg

  • Inactive Ingredient


    Bio-Energetically Enhanced, taste free, pure water base.

    Reference image sinus.jpg

  • Dosage and Administration

    Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

    Adult dose: 3 pump sprays 3 times per day. Use additionally as needed.

    Children 2-12 years: 2 pump sprays 3 times per day. Use additionally as needed.


    Reference image sinus.jpg

  • Purpose

    HPUS active ingredients       Purpose


    Apis mellifica............................swollen, red eyelids, vertigo with sneezing

    Baptisia tinctoria.......................eyelids heavy, difficult breathing

    Colocynthis..............................headaches, swelling of face

    Hepar sulphuris calcareum.......sore nostrils, sneezing, running nose

    Histaminum hydrochloricum......dries mucus membranes, sinus headache

    Hydrastis canadensis...............profuse nasal discharge

    Ignatia amara...........................headaches, tonsils inflamed, and swollen, dry cough

    Kali bichromicum......................headaches, violent sneezing

    Lemna minor............................dry throat, post-nasal dripping

    Mercurius vivus........................thick mucus, runny nose, sneezing

    Pulsatilla...................................itching, burning eyes, loss of smell, congestion and pain

    Rhus toxicodendron..................headaches, face and throat pains

    Sabadilla...................................sneezing, runny nose, sinus inflammation

    Thuja occidentalis......................fever, tinnitus, vertigo

    Reference image sinus.jpg
  • Warnings

    If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

    Other Information

    Tamper resistant for your protection. Use only if safety seal is intact.


    Reference image sinus.jpg
  • OTC Keep Out Of Reach Of Children

    Keep out of reach of children.

    Reference image sinus.jpg

  • Indications and Usage

    Uses temporarily relieves symptoms due to sinus discomforts associated with inflamed sinuses, hay fever or upper respiratory allergies:

    • sinus pain and pressure
    • runny nose
    • sinus headaches
    • sore throat
    • nasal congestion
    • dry mucus membranes
    • sneezing
    • itchy, burning eyes
    Reference image sinus.jpg
  • PRINCIPAL DISPLAY PANEL


    Image of carton label


    King Bio Inc.

    3 Westside Drive

    Asheville, NC 28806

    www.kingbio.com


    Reference image sinus.jpg

  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF 
    natural medicine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-5134
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]  in 59 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT10 [hp_X]  in 59 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP10 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE10 [hp_X]  in 59 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (CHLORIDE ION - UNII:Q32ZN48698) HISTAMINE DIHYDROCHLORIDE10 [hp_X]  in 59 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM DICHROMATE10 [hp_X]  in 59 mL
    LEMNA MINOR (UNII: 621HHM46SV) (LEMNA MINOR - UNII:621HHM46SV) LEMNA MINOR10 [hp_X]  in 59 mL
    MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY10 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 59 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 59 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED10 [hp_X]  in 59 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-5134-21 in 1 BOX
    159 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/06/2011
    Labeler - King Bio Inc (617901350)
    Registrant - King Bio Inc (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture
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