SINUS- pulsatilla, euphorbium, allium cepa, histaminum, luffa operculata, sabadilla, hepar sulfur. liquid

SINUS by

Drug Labeling and Warnings

SINUS by is a Homeopathic medication manufactured, distributed, or labeled by Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Pulsatilla 2X, Euphorbium 4X, Allium Cepa 6X, Histaminum 6X, Luffa Operculata 6X, Sabadilla 6X, Hepar Sulfur 12X

INDICATIONS & USAGE

INDICATIONS: For the temporary relief of acute and chronic rhinitis, sinusitis and hayfever.

WARNINGS

WARNINGS:

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

KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Keep out of reach of children.

DOSAGE & ADMINISTRATION

DOSAGE: 1 spray in each nostril three to eight times daily.

OTHER SAFETY INFORMATION

TAMPER EVIDENT: There is a safety seal on the neck and cap of the bottle. Do not use this product if the safety seal is broken or missing.

Store tightly closed, protect from excessive heat, light and moisture.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Demineralized Water, Sodium Chloride, Benzalkonium Chloride.

QUESTIONS

Manufactured for:

Be Well Homeopathics Inc.

Miami, Florida 33178

1-877-438-3042

www.bewellhomeo.com

PRINCIPAL DISPLAY PANEL

NDC: 66492-004-02

Be Well Homeopathics™

SINUS NASAL SPRAY

30 ml

Temporary relief of acute and chronic rhinitis, sinusitis and hayfever.

INGREDIENTS AND APPEARANCE

SINUS 
pulsatilla, euphorbium, allium cepa, histaminum, luffa operculata, sabadilla, hepar sulfur. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66492-004
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	2 [hp_X]  in 1 mL
EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K)	EUPHORBIA RESINIFERA RESIN	4 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	6 [hp_X]  in 1 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	6 [hp_X]  in 1 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66492-004-02	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2017

Labeler - Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics (052584997)

Registrant - OHM PHARMA INC. (030572478)

Establishment
Name	Address	ID/FEI	Business Operations
OHM PHARMA INC.		030572478	manufacture(66492-004)