SPL v2
SPL
SPL Set ID df6edd7a-3ca6-4946-b083-1193f4b1d226
Route
ORAL
Published
Effective Date 2017-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Recutita (5 [hp_C]) Arnica Montana Borate Ion Hypericum Perforatum
Inactive Ingredients
Water Sorbitol Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-03-03

Description

Active Ingredients HPUS : Chamomilla (German chamomile) 5C Arnica montana (Leopard's bane) 5C Borax (Sodium borate) 5C Hypericum perforatum ( St John's wort) 5C


Medication Information

Warnings and Precautions

Warnings

Do not use if imprinted shrink seal neckband is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

Indications and Usage

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething*:

• gum inflammation

• gum pain

• fever

• diarrhea

• restlessness and irritability

Dosage and Administration

Directions

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

Children 6 months to 2 years old: 0.5 ml orally every 8 hours or 3 times a day.

Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.

Description

Active Ingredients HPUS : Chamomilla (German chamomile) 5C Arnica montana (Leopard's bane) 5C Borax (Sodium borate) 5C Hypericum perforatum ( St John's wort) 5C

Section 44425-7

Other Information

Store at room temperature.   

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive Ingredients

Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, orange oil.

Section 51945-4

LABEL

Section 55105-1



Purpose

Gum pain, restlessness, irritability and agitation

Toothache and fever

Gum inflammation and diarrhea

Dental nerve pain

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Section 55106-9

Active Ingredients HPUS:

Chamomilla (German chamomile) 5C

Arnica montana (Leopard's bane) 5C

Borax (Sodium borate) 5C

Hypericum perforatum ( St John's wort) 5C


Structured Label Content

Indications and Usage (34067-9)

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething*:

• gum inflammation

• gum pain

• fever

• diarrhea

• restlessness and irritability

Dosage and Administration (34068-7)

Directions

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

Children 6 months to 2 years old: 0.5 ml orally every 8 hours or 3 times a day.

Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.

Warnings and Precautions (34071-1)

Warnings

Do not use if imprinted shrink seal neckband is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

Section 44425-7 (44425-7)

Other Information

Store at room temperature.   

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive Ingredients

Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, orange oil.

Section 51945-4 (51945-4)

LABEL

Section 55105-1 (55105-1)



Purpose

Gum pain, restlessness, irritability and agitation

Toothache and fever

Gum inflammation and diarrhea

Dental nerve pain

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Chamomilla (German chamomile) 5C

Arnica montana (Leopard's bane) 5C

Borax (Sodium borate) 5C

Hypericum perforatum ( St John's wort) 5C


Advanced Ingredient Data


Raw Label Data

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