Label: SINUS RELIEF FORMULA (pulsatilla- pratensis, sinapis nigra, luffa operculata, euphorbium officinarum, guaiacum, mercurius sulphuratus ruber spray

  • NDC Code(s): 83027-0105-1
  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Pulsatilla 4X, Sinapis Nigra 4X, Luffa Operculata 5X, Euphorbium Officinarum 8X, Guaiacum 12X, Mercurius Sulphuratus Ruber 12X.

  • PURPOSE:

    Aids in temporary relief of sinus congestion and irritation.†

    †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 sinus congestion and irritation.†

    †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 83027-0105-1

    SINUS RELIEF

    FORMULA

    2 FL. OZ (60 ml)

    SINUS RELIEF  FORMULA

  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF FORMULA 
    pulsatilla (pratensis), sinapis nigra, luffa operculata, euphorbium officinarum, guaiacum, mercurius sulphuratus ruber spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE4 [hp_X]  in 1 mL
    BLACK MUSTARD SEED (UNII: 8LTY55LQ8D) (BLACK MUSTARD SEED - UNII:8LTY55LQ8D) BLACK MUSTARD SEED4 [hp_X]  in 1 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT5 [hp_X]  in 1 mL
    EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN8 [hp_X]  in 1 mL
    GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6) GUAIACUM OFFICINALE RESIN12 [hp_X]  in 1 mL
    MERCURIC SULFIDE (UNII: ZI0T668SF1) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC SULFIDE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83027-0105-160 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)