Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 7333663c-a79d-44d2-93ac-a9254c2b32c5
Route
ORAL
Published
Effective Date 2021-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Goldenseal (6 [hp_X]) Onion (12 [hp_X]) Ambrosia Artemisiifolia Arsenic Cation (3+) Dichromate Ion Nutmeg Pulsatilla Pratensis Whole Sepia Officinalis Juice Solidago Virgaurea Flowering Top
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-10-09

Description

(in each drop):  11.10% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Hydrastis Canadensis 6X, Kali Bichromicum 12X, Nux Moschata 12X, Pulsatilla (Pratensis) 12X, Sepia 12X, Solidago Virgaurea 12X; 0.10% of Echinacea (Angustifolia) 3X.


Medication Information

Description

(in each drop):  11.10% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Hydrastis Canadensis 6X, Kali Bichromicum 12X, Nux Moschata 12X, Pulsatilla (Pratensis) 12X, Sepia 12X, Solidago Virgaurea 12X; 0.10% of Echinacea (Angustifolia) 3X.

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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800-869-8078

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

May temporarily relieve allergic rhinitis with runny nose, nasal mucus with yellow green discharge, pain and swelling of sinus cavities, and postnasal drip.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

(in each drop): 11.10% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Hydrastis Canadensis 6X, Kali Bichromicum 12X, Nux Moschata 12X, Pulsatilla (Pratensis) 12X, Sepia 12X, Solidago Virgaurea 12X; 0.10% of Echinacea (Angustifolia) 3X.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

SINUTONE

1 fl. oz. (30 ml)

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.


Structured Label Content

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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800-869-8078

Directions: (DIRECTIONS:)

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

May temporarily relieve allergic rhinitis with runny nose, nasal mucus with yellow green discharge, pain and swelling of sinus cavities, and postnasal drip.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): 11.10% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Hydrastis Canadensis 6X, Kali Bichromicum 12X, Nux Moschata 12X, Pulsatilla (Pratensis) 12X, Sepia 12X, Solidago Virgaurea 12X; 0.10% of Echinacea (Angustifolia) 3X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

SINUTONE

1 fl. oz. (30 ml)

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

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