Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID edc8eb65-84b3-433f-8aad-7a741f563718
Route
ORAL
Published
Effective Date 2023-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alfalfa (3 [hp_X]) Avena Sativa Flowering Top (6 [hp_X]) Iodine (12 [hp_X]) Lycoperdon Utriforme Fruiting Body (30 [hp_X]) Formaldehyde Solution Sus Scrofa Pituitary Gland Manganous Cation Chloride Ion Kerosene Pulsatilla Pratensis Whole Toxicodendron Pubescens Leaf Turpentine Oil Thyroid, Bovine Cortisone
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-04-17

Description

(in each drop): 9.06% of Bovista 12X, Cortisone Aceticum 30X, Formalinum 12X, Hypophysis Suis 12X, Manganum Aceticum 12X, Natrum Muriaticum 12X, Petroleum 12X, Pulsatilla 12X, Rhus Tox 12X, Terebinthina 12X, Thyroidinum 12X; 0.10% of Alfalfa 3X, Avena Sativa 3X, Iodium 6X.

Purpose

For temporary relief of sinus congestion, dry cough in the evening and rhinitis.** **Claims based on traditional homeopathic practice, not medical evidence. Not FDA evaluated.


Medication Information

Purpose

For temporary relief of sinus congestion, dry cough in the evening and rhinitis.** **Claims based on traditional homeopathic practice, not medical evidence. Not FDA evaluated.

Description

(in each drop): 9.06% of Bovista 12X, Cortisone Aceticum 30X, Formalinum 12X, Hypophysis Suis 12X, Manganum Aceticum 12X, Natrum Muriaticum 12X, Petroleum 12X, Pulsatilla 12X, Rhus Tox 12X, Terebinthina 12X, Thyroidinum 12X; 0.10% of Alfalfa 3X, Avena Sativa 3X, Iodium 6X.

Purpose:

For temporary relief of sinus congestion, dry cough in the evening and rhinitis.**

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

Warnings:

If pregnant or breastfeeding, 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:

For temporary relief of sinus congestion, dry cough in the evening and rhinitis.**

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

Active Ingredients:

(in each drop): 9.06% of Bovista 12X, Cortisone Aceticum 30X, Formalinum 12X, Hypophysis Suis 12X, Manganum Aceticum 12X, Natrum Muriaticum 12X, Petroleum 12X, Pulsatilla 12X, Rhus Tox 12X, Terebinthina 12X, Thyroidinum 12X; 0.10% of Alfalfa 3X, Avena Sativa 3X, Iodium 6X.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

COSMESTAT

1 fl. oz. (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (PURPOSE:)

For temporary relief of sinus congestion, dry cough in the evening and rhinitis.**

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

Warnings: (WARNINGS:)

If pregnant or breastfeeding, 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:)

For temporary relief of sinus congestion, dry cough in the evening and rhinitis.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): 9.06% of Bovista 12X, Cortisone Aceticum 30X, Formalinum 12X, Hypophysis Suis 12X, Manganum Aceticum 12X, Natrum Muriaticum 12X, Petroleum 12X, Pulsatilla 12X, Rhus Tox 12X, Terebinthina 12X, Thyroidinum 12X; 0.10% of Alfalfa 3X, Avena Sativa 3X, Iodium 6X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

COSMESTAT

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.


Advanced Ingredient Data


Raw Label Data

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