SINUSIN - pulsatilla vulgaris and euphorbia resinifera resin and luffa operculata fruit and mercuric iodide and silver nitrate and calcium sulfide and sinusitisinum and influenza a virus a/singapore/6/86 (h1n1) hemagglutinin antigen (heat inactivated) and influenza a virus a/beijing/32/92 (h3n2) hemagglutinin antigen (heat inactivated) and influenza b virus b/panama/45/90 hemagglutinin antigen (heat inactivated) liquid
Heel Inc

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.

----------

SINUSIN Oral Drops

KEEP OUT OF REACH OF CHILDREN

Keep this and all medications out of the reach of children.

INDICATIONS AND USAGE

For the temporary relief of:

Nasal Congestion
Rhinitis and Sinusitis
Cold and Flu Nasal Symptoms

WARNINGS

If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.

DOSAGE AND ADMINISTRATION

Adults and Children above 11 years: 10 drops orally 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.

ACTIVE INGREDIENTS

Each 50ml contains: Pulsatilla 2X, Euphorbium officinarum 6X, Luffa operculata 6X, Mercurius iodatus ruber 6X, Influenzinum 8X, Argentum nitricum 10X, Hepar sulphuris calcareum 10X, Sinusitisinum 13X 0.5 ml each.

INACTIVE INGREDIENTS

Ethanol, Purified Water USP

PURPOSE

Nasal Congestion, Rhinitis and Sinusitis, Cold and Flu Nasal Symptoms

SINUSIN
pulsatilla vulgaris and euphorbia resinifera resin and luffa operculata fruit and mercuric iodide and silver nitrate and calcium sulfide and sinusitisinum and influenza a virus a/singapore/6/86 (h1n1) hemagglutinin antigen (heat inactivated) and influenza a virus a/beijing/32/92 (h3n2) hemagglutinin antigen (heat inactivated) and influenza b virus b/panama/45/90 hemagglutinin antigen (heat inactivated) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50114-3250
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	2 [hp_X] in 50 mL
EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K)	EUPHORBIA RESINIFERA RESIN	6 [hp_X] in 50 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	6 [hp_X] in 50 mL
MERCURIC IODIDE (UNII: R03O05RB0P) (MERCURIC IODIDE - UNII:R03O05RB0P)	MERCURIC IODIDE	6 [hp_X] in 50 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	10 [hp_X] in 50 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFIDE	10 [hp_X] in 50 mL
SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5)	SINUSITISINUM	13 [hp_X] in 50 mL
INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) (UNII: DRA5YV248Q) (INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) - UNII:DRA5YV248Q)	INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)	8 [hp_X] in 50 mL
INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) (UNII: 0835GZ42BC) (INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) - UNII:0835GZ42BC)	INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)	8 [hp_X] in 50 mL
INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) (UNII: 790PSW8427) (INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) - UNII:790PSW8427)	INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED)	8 [hp_X] in 50 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50114-3250-4	50 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/31/2007

Labeler - Heel Inc (102783016)

Name	Address	ID/FEI	Business Operations
Establishment
Heel Inc		102783016	manufacture