SINUTONE- echinacea, hydrastis canadensis, allium cepa, ambrosia artemesiaefolia, arsenicum album, kali bichromicum, nux moschata, pulsatilla, sepia, solidago virgaurea, liquid

Sinutone by

Drug Labeling and Warnings

Sinutone by is a Homeopathic medication manufactured, distributed, or labeled by Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:  Echinacea 3X, Hydrastis canadensis 3X, Allium cepa 12X, Ambrosia artemesiaefolia 12X, Arsenicum album 12X, Kali bichromicum 12X, Nux moschata 12X, Pulsatilla 12X,  Sepia 12X, Solidago virgaurea 12X.

PURPOSE

INDICATIONS:  For temporary relief of allergic rhinitis with runny nose, nasal mucous with yellow green discharge, pain and swelling of sinus cavities and postnasal drip.

WARNINGS

WARNINGS:  If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.  Store in a cool, dry place.

DOSAGE & ADMINISTRATION

SUGGESTED USE:  Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.  If symptoms persist, consult your health care professional.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:  Demineralized water, 20% Ethanol.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

INDICATIONS:  For temporary relief of allergic rhinitis with runny nose, nasal mucous with yellow green discharge, pain and swelling of sinus cavities and postnasal drip.

QUESTIONS

Dist by  Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINUTONE

Homeopathic Remedy

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

SINUTONE 
echinacea, hydrastis canadensis, allium cepa, ambrosia artemesiaefolia, arsenicum album, kali bichromicum, nux moschata, pulsatilla, sepia, solidago virgaurea, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0295
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA (UNII: 4N9P6CC1DX) (ECHINACEA - UNII:4N9P6CC1DX)	ECHINACEA	3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	12 [hp_X]  in 1 mL
AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A)	AMBROSIA ARTEMISIIFOLIA	12 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM DICHROMATE	12 [hp_X]  in 1 mL
NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9)	NUTMEG	12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X]  in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	12 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57520-0295-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/10/2010

Labeler - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture