Oralsoothe

Oralsoothe
SPL v1
SPL
SPL Set ID 8393be5c-a89a-4ca9-b2e5-44bcd5475194
Route
ORAL
Published
Effective Date 2013-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (8 [hp_X]) Calcium Cation (3 [hp_X]) Matricaria Recutita (6 [hp_C]) Passiflora Incarnata Flowering Top
Inactive Ingredients
Citric Acid Monohydrate Starch, Corn Potassium Sorbate Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-01-08

Description

Relieves pain, crankiness & crying during teething


Medication Information

Warnings and Precautions

Warnings: If symptoms persist or worsen, consult a healthcare professional.

Indications and Usage

Uses: Soothing homeopathic remedy for teething in babies and children.

Dosage and Administration

Directions: Babies:Sprinkle 1 pinch on the tongue when needed. Repeat after 20 minutes for up to 10 doses if needed.

Description

Relieves pain, crankiness & crying during teething

Section 34076-0

The letters HPUS indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States.

All Native Remedies health products are specially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, Fl 33487

Phone: 1.877.289.1235

International:+1.561.999.8857

Contains no artificial flavors or artificial colors. No gluten added.

Section 34088-5

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

Section 50565-1

Keep this and all medication out of reach of children.

Section 51727-6

Inactive Ingredients: Citric acid, corn starch, potassium sorbate, sucrose.

Section 51945-4

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Relieves pain, crankiness & crying during teething

Section 55106-9

Active Ingredients: Each dose contains equal parts of: Calc fluor 8X HPUS, Calc phos 8X HPUS, Chamomilla 3X HPUS, Chamomilla 6C HPUS, Passiflora 3X HPUS.


Structured Label Content

Indications and Usage (34067-9)

Uses: Soothing homeopathic remedy for teething in babies and children.

Dosage and Administration (34068-7)

Directions: Babies:Sprinkle 1 pinch on the tongue when needed. Repeat after 20 minutes for up to 10 doses if needed.

Warnings and Precautions (34071-1)

Warnings: If symptoms persist or worsen, consult a healthcare professional.

Section 34076-0 (34076-0)

The letters HPUS indicate that the components in this products are officially monographed in the Homeopathic Pharmacopoeia of the United States.

All Native Remedies health products are specially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, Fl 33487

Phone: 1.877.289.1235

International:+1.561.999.8857

Contains no artificial flavors or artificial colors. No gluten added.

Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep this and all medication out of reach of children.

Section 51727-6 (51727-6)

Inactive Ingredients: Citric acid, corn starch, potassium sorbate, sucrose.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Relieves pain, crankiness & crying during teething

Section 55106-9 (55106-9)

Active Ingredients: Each dose contains equal parts of: Calc fluor 8X HPUS, Calc phos 8X HPUS, Chamomilla 3X HPUS, Chamomilla 6C HPUS, Passiflora 3X HPUS.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)