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

DEFEND Sinus by

Drug Labeling and Warnings

DEFEND Sinus by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

INGREDIENTS AND APPEARANCE

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

Product 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 (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3187) , pack(54973-3187)