Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID d37b43d8-1d1b-49be-93c8-2436c4d1587f
Route
ORAL
Published
Effective Date 2015-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (30 [hp_C]) Atropa Belladonna (8 [hp_X]) Borate Ion (3 [hp_X]) Calcium Cation (6 [hp_X]) Matricaria Recutita (9 [hp_X]) Phosphate Ion Magnesium Cation Nitric Acid Delphinium Staphisagria Seed
Inactive Ingredients
Water Alcohol Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-08-18

Description

Aconitum Napellus 30C, Belladonna 30C, Borax 30C, Calcarea Phosphorica 8X, Chamomilla 3X, Kali Phosphoricum 6X, Magnesia Phosphorica 8X, Nitricum Acidum 30C, Staphysagria 9X


Medication Information

Description

Aconitum Napellus 30C, Belladonna 30C, Borax 30C, Calcarea Phosphorica 8X, Chamomilla 3X, Kali Phosphoricum 6X, Magnesia Phosphorica 8X, Nitricum Acidum 30C, Staphysagria 9X

Warnings:

If symptoms persist, consult a doctor.

If pregnant or breast-feeding, ask a doctor before use.

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

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Questions:

Manufactured for VitaMed, LLC, 311 S Division St.,

Carson City, NV 89703. Phone number: (800) 270-7379

Directions:

Apply 2 drops under the tongue, or on the affected gum area, for each year of age as needed, up to 6 times per day. Use one drop per dose for children under 1 year of age.

Indications:

May temporarily relieve symptoms of teething: swelling, inflammation, pain.**

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

Active Ingredients:

Aconitum Napellus 30C, Belladonna 30C, Borax 30C, Calcarea Phosphorica 8X, Chamomilla 3X, Kali Phosphoricum 6X, Magnesia Phosphorica 8X, Nitricum Acidum 30C, Staphysagria 9X

Inactive Ingredients:

Glycerin 10% v/v, Organic alcohol 9% v/v, Purified water.

Package Label Display

Vita Med

BabyTeeth

Teething

HOMEOPATHIC

1.0 FL OZ. (30 ml)

Made in USA

with U.S. and foreign components

Keep Out of Reach of Children

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


Structured Label Content

Warnings: (WARNINGS:)

If symptoms persist, consult a doctor.

If pregnant or breast-feeding, ask a doctor before use.

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

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Questions: (QUESTIONS:)

Manufactured for VitaMed, LLC, 311 S Division St.,

Carson City, NV 89703. Phone number: (800) 270-7379

Directions: (DIRECTIONS:)

Apply 2 drops under the tongue, or on the affected gum area, for each year of age as needed, up to 6 times per day. Use one drop per dose for children under 1 year of age.

Indications: (INDICATIONS:)

May temporarily relieve symptoms of teething: swelling, inflammation, pain.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

Aconitum Napellus 30C, Belladonna 30C, Borax 30C, Calcarea Phosphorica 8X, Chamomilla 3X, Kali Phosphoricum 6X, Magnesia Phosphorica 8X, Nitricum Acidum 30C, Staphysagria 9X

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Glycerin 10% v/v, Organic alcohol 9% v/v, Purified water.

Package Label Display (PACKAGE LABEL DISPLAY)

Vita Med

BabyTeeth

Teething

HOMEOPATHIC

1.0 FL OZ. (30 ml)

Made in USA

with U.S. and foreign components

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 call a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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