Label: POLYHESION FORMULA- sanguinaria canadensis, nitricum acidum, teucrium marum, thuja occidentalis, sanguinarinum nitricum, calcarea carbonica, phosphorus spray

  • NDC Code(s): 83027-0104-1
  • 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 12, 2023

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

  • ACTIVE INGREDIENTS:

    Sanguinaria Canadensis 3X, Nitricum Acidum 6X, Teucrium Marum 6X, , Thuja Occidentalis 6X, Sanguinarinum Nitricum 15X, Calcarea Carbonica 30X, Phosphorus 30X.

  • PURPOSE:

    Aids in temporary relief of cramping and pain in the abdomen.†

    †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 cramping and pain in the abdomen.†

    †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 83027-0104-1

    POLYHESION

    FORMULA

    2 FL. OZ (60 ml)

    POLYHESION  FORMULA

  • INGREDIENTS AND APPEARANCE
    POLYHESION FORMULA 
    sanguinaria canadensis, nitricum acidum, teucrium marum, thuja occidentalis, sanguinarinum nitricum, calcarea carbonica, phosphorus spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0104
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_X]  in 1 mL
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID6 [hp_X]  in 1 mL
    TEUCRIUM MARUM WHOLE (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA) TEUCRIUM MARUM WHOLE6 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]  in 1 mL
    SANGUINARINE NITRATE (UNII: BOP122S791) (NITRATE ION - UNII:T93E9Y2844) SANGUINARINE NITRATE15 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83027-0104-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/12/2023
    Labeler - Nutritional Specialties, Inc. (032744609)