Label: DEFEND SINUS- oyster shell calcium carbonate, crude, goldenseal, potassium dichromate, and pulsatilla vulgaris tablet, soluble
- NDC Code(s): 54973-3187-1
- Packager: Hyland's 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 December 12, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients Purpose "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Calcarea Carbonica 3X HPUS head congestion, headache, pressure and aches in eyes Hydrastis Canadensis 6X HPUS dull, heavy frontal headache over eyes Kali Bichromicum 6X HPUS watery, itchy, irritating eyes, runny nose, frontal sinus pressure, nasal congestion Pulsatilla 6X HPUS pain in forehead, nasal pain and pressure, sneezing - Uses
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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)
- Directions
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 40 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
DEFEND SINUS
oyster shell calcium carbonate, crude, goldenseal, potassium dichromate, and pulsatilla vulgaris tablet, solubleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3187 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 3 [hp_X] GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 6 [hp_X] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color green (Light Greenish/Beige) Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3187-1 1 in 1 CARTON 07/01/2014 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/01/2014 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3187) , pack(54973-3187)