Label: DEFEND SINUS- oyster shell calcium carbonate, crude, goldenseal, potassium dichromate, and pulsatilla vulgaris tablet, soluble

  • 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 December 12, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Calcarea Carbonica 3X HPUShead congestion, headache, pressure and aches in eyes
    Hydrastis Canadensis 6X HPUSdull, heavy frontal headache over eyes
    Kali Bichromicum 6X HPUSwatery, itchy, irritating eyes, runny nose, frontal sinus pressure, nasal congestion
    Pulsatilla 6X HPUSpain in forehead, nasal pain and pressure, sneezing
  • Uses

    Temporarily relieves the symptoms of sinus pain and pressure, headache, and nasal congestion due to common cold or allergies.

  • Warnings

    As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if:

    • Symptoms persist for more than 7 days or worsen
    • Symptoms are accompanied by high fever (101°F)

    Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

    Do not use if imprinted tamper band is broken or missing.

    In case of emergency, contact a medical professional or a poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • Directions

    Adults and children 12 years and over: dissolve 2-3 tablets under tongue every 4 hours or as needed. Children 6 to under 12 years: dissolve 1-2 tablets under tongue every 4 hours or as needed.

  • Inactive ingredients

    Acacia Gum, Lactose N.F.

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 40 Tablet Bottle Carton

    NDC 54973-3187-1
    HOMEOPATHIC

    SINCE 1903
    Hyland's

    DEFEND™

    SINUS*

    NON-DROWSY

    Natural, Safe & Effective Relief of:

    Sinus Pressure

    Nasal Congestion

    Headache

    Sinus Pain

    40
    QUICK-DISSOLVING TABLETS

    Principal Display Panel - 40 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DEFEND SINUS 
    oyster shell calcium carbonate, crude, goldenseal, potassium dichromate, and pulsatilla vulgaris tablet, soluble
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3187
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE3 [hp_X]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorgreen (Light Greenish/Beige) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3187-11 in 1 CARTON07/01/2014
    140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2014
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3187) , pack(54973-3187)
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