Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID c55e6188-bdb6-4445-bbe2-1c554250919b
Route
ORAL
Published
Effective Date 2014-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Phytolacca Americana Root (12 [hp_X]) Trifolium Pratense Flower Calcium Cation Potassium Cation Nitric Acid Phosphoric Acid Sulfur Iodide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-10-30

Description

ECHINACEA (ANGUSTIFOLIA) 3X,  PHYTOLACCA DECANDRA 3X,  TRIFOLIUM PRATENSE 3X,  CALCAREA IODATA 12X,  KALI MURIATICUM 12X,  NITRICUM ACIDUM 12X,  PHOSPHORICUM ACIDUM 12X,  SULPHUR IODATUM 12X


Medication Information

Description

ECHINACEA (ANGUSTIFOLIA) 3X,  PHYTOLACCA DECANDRA 3X,  TRIFOLIUM PRATENSE 3X,  CALCAREA IODATA 12X,  KALI MURIATICUM 12X,  NITRICUM ACIDUM 12X,  PHOSPHORICUM ACIDUM 12X,  SULPHUR IODATUM 12X

Warnings:

If pregnant or breast-feeding, ask a health care 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 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.

Questions:

Dist. by:

Think Healthy Enterprises, LLC

8010 E. McDowell Rd., Ste. 101

Scottsdale, AZ 85257

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications:

For temporary relief of swellings with heat and inflammation, and sore throat.

Active Ingredients:

ECHINACEA (ANGUSTIFOLIA) 3X,  PHYTOLACCA DECANDRA 3X,  TRIFOLIUM PRATENSE 3X,  CALCAREA IODATA 12X,  KALI MURIATICUM 12X,  NITRICUM ACIDUM 12X,  PHOSPHORICUM ACIDUM 12X,  SULPHUR IODATUM 12X

Inactive Ingredients:

Demineralized water, 25% Ethanol

Package Label Display:

Vitanya

Frequency

Drops

HOMEOPATHIC

1 fl. oz. (30 ml)  25% 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.


Structured Label Content

Warnings: (WARNINGS:)

If pregnant or breast-feeding, ask a health care 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 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.

Questions: (QUESTIONS:)

Dist. by:

Think Healthy Enterprises, LLC

8010 E. McDowell Rd., Ste. 101

Scottsdale, AZ 85257

Directions: (DIRECTIONS:)

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For temporary relief of swellings with heat and inflammation, and sore throat.

Active Ingredients: (ACTIVE INGREDIENTS:)

ECHINACEA (ANGUSTIFOLIA) 3X,  PHYTOLACCA DECANDRA 3X,  TRIFOLIUM PRATENSE 3X,  CALCAREA IODATA 12X,  KALI MURIATICUM 12X,  NITRICUM ACIDUM 12X,  PHOSPHORICUM ACIDUM 12X,  SULPHUR IODATUM 12X

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

Vitanya

Frequency

Drops

HOMEOPATHIC

1 fl. oz. (30 ml)  25% Ethanol

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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