Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID fc1953c7-2ff3-4909-a2dd-5797988bc270
Route
ORAL
Published
Effective Date 2015-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Purpurea (2 [hp_X]) Plantago Major (3 [hp_X]) Baptisia Tinctoria Root (12 [hp_X]) Phytolacca Americana Root (15 [hp_X]) Apis Mellifera Atropa Belladonna Lachesis Muta Venom Mercurius Solubilis Calcium Sulfide
Inactive Ingredients
Clove Goldenseal Myrrh Sage Thyme Glycerin Water Alcohol Menthol Methyl Salicylate Stevia Rebaudiuna Leaf Spearmint Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-10-09

Description

Echinacea Purpurea 2X, Plantago Major 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 3X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.


Medication Information

Description

Echinacea Purpurea 2X, Plantago Major 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 3X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

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.

WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by a physician.

Recommended for Professional Use.

Questions:

Manufactured Exclusively For:

NSI and Nova Aurora Corp

P.O. Box 97227

Pittsburgh, PA 15209

www.phpltd.com

Directions:

Adults and children over 12 years of age, at the onset of symptoms, spray throat every 3 hours. Consult a physician for use in children under 12 years of age.

Indications:

For the temporary symptomatic relief of minor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.

Active Ingredients:

Echinacea Purpurea 2X, Plantago Major 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 3X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

Inactive Ingredients:

Demineralized Water, 23% Ethanol, Glycerin, Herbal Base [Clove (Flower), Goldenseal (Root), Myrrh (Resin), Sage (Leaf), Thyme (Leaf)], Marshmallow Flavor, Menthol, Spearmint Oil (flowering tops), Stevia (leaf) Extract, Teaberry Oil Flavor.

Package Label Display:

PROFESSIONAL HEALTH PRODUCTS

SORE THROAT

SPRAY

HOMEOPATHIC

C63 (reorder code)

NET 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.

WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by a physician.

Recommended for Professional Use.

Questions: (QUESTIONS:)

Manufactured Exclusively For:

NSI and Nova Aurora Corp

P.O. Box 97227

Pittsburgh, PA 15209

www.phpltd.com

Directions: (DIRECTIONS:)

Adults and children over 12 years of age, at the onset of symptoms, spray throat every 3 hours. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For the temporary symptomatic relief of minor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.

Active Ingredients: (ACTIVE INGREDIENTS:)

Echinacea Purpurea 2X, Plantago Major 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 3X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 23% Ethanol, Glycerin, Herbal Base [Clove (Flower), Goldenseal (Root), Myrrh (Resin), Sage (Leaf), Thyme (Leaf)], Marshmallow Flavor, Menthol, Spearmint Oil (flowering tops), Stevia (leaf) Extract, Teaberry Oil Flavor.

Package Label Display: (PACKAGE LABEL DISPLAY:)

PROFESSIONAL HEALTH PRODUCTS

SORE THROAT

SPRAY

HOMEOPATHIC

C63 (reorder code)

NET 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

All Sections (JSON)