Label: SINU HELP- euphorbium officinarum, hepar sulphur calcareum, kali bichromicum, luffa operculata, pulsatilla, teucrium marum. liquid

  • NDC Code(s): 86066-002-59
  • Packager: Surefreight Global LLC, DBA PRANAPETS
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 28, 2017

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Euphorbium officinarum 12X, Hepar sulphur calcareum 12C, Kali bichromicum 30C, Luffa operculata 6X, Pulsatilla 30C, Teucrium marum 12X.

    * The letters "HPUS" indicate that components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

  • INDICATIONS & USAGE

    USES: Temporarily relieves symptoms commonly associated with sinus infections in cats and dogs.**

    ** This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

  • WARNINGS

    WARNINGS:

    • KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a poison control center right away.
    • IF PREGNANT OR BREAST-FEEDING, consult a veterinarian before use.
    • If symptoms worsen or persist for more than a week, stop use and consult a veterinarian.
    • Do not use if TAMPER EVIDENT neck seal is broken or missing.
  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Shake well before use. Mix with food or administer directly in mouth 3 - 5 times a day.

    • Cats and dogs under 20 lbs: 10 drops
    • Dogs 20 - 50 lbs: 15 drops
    • Dogs over 50 lbs: 20 drops

    In acute cases, one dose every 15 minutes up to six doses may be provided. Repeat as needed for prevention.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Citric Acid, Vegetable Glycerin USP, Potassium Sorbate, Purified Water.

  • QUESTIONS

    Distributed by:

    PRANA PETS / Boca Raton, FL 33432

    www.pranapets.com

  • PRINCIPAL DISPLAY PANEL

    PRANA PETS

    Sinu Help

    Relieves symptoms related to sinus infections in cats and dogs**

    Homeopathic Remedy

    2 fl oz (59 mL) / Alcohol Free

    Made in USA

    Pharmaceutical Grade Natural Remedy

    2oz bottle label

  • INGREDIENTS AND APPEARANCE
    SINU HELP 
    euphorbium officinarum, hepar sulphur calcareum, kali bichromicum, luffa operculata, pulsatilla, teucrium marum. liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86066-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN12 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_C]  in 59 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE30 [hp_C]  in 59 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT6 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS30 [hp_C]  in 59 mL
    TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA) TEUCRIUM MARUM12 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86066-002-5959 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2016
    Labeler - Surefreight Global LLC, DBA PRANAPETS (079866524)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM PHARMA INC.030572478manufacture, api manufacture