Sinutone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2021-10-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:32:08

Label at a glance#

ProductSinutone
Active ingredientECHINACEA ANGUSTIFOLIA, GOLDENSEAL, ONION, AMBROSIA ARTEMISIIFOLIA, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SOLIDAGO VIRGAUREA FLOWERING TOP, ARSENIC TRIOXIDE, POTASSIUM DICHROMATE, NUTMEG
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Echinacea (Angustifolia) 3X, Hydrastis Canadensis 6X, Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Kali Bichromicum 12X, Nux Moschata 12X, Pulsatilla (Vulgaris) 12X, Sepia 12X, Solidago Virgaurea 12X.

INDICATIONS:

OTC - PURPOSE SECTION

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

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

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


**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.  201 Apple Blvd.
Woodbine, IA 51579   800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

SINUTONE

1 fl. oz. (30 ml)

SinutoneSinutone

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-042844911-0428-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d5f57765-0b88-4549-9256-60ad17b32b11e5e4b5c3-123f-4ff2-8972-1c73c28c4f612021-10-19WarningsExact identifier
spl id: d5f57765-0b88-4549-9256-60ad17b32b11
spl set id: e5e4b5c3-123f-4ff2-8972-1c73c28c4f61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.