oralsoothe

oralsoothe
SPL v4
SPL
SPL Set ID 016b8e20-b260-44cc-a851-6ade29e60488
Route
oral
Published
Effective Date 2010-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
passiflora incarnata top (3 [hp_X]) matricaria recutita (6 [hp_X]) calcium cation (6 [hp_C])
Inactive Ingredients
sucrose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
unapproved homeopathic active Since 2010-01-01

Description

Relieves pain, crankiness and crying during teething


Medication Information

Warnings and Precautions

Contains no gluten, artificial flavors, colors or preservatives.Safe for all ages.

Active Ingredient

Ingredients: Each dose contains equal parts of Passiflora (3X) (HPUS), Chamomilla (3X) (HPUS), Calc fluor (6X) (HPUS), Calc phos (6X) (HPUS), Chamomilla (6C) (HPUS)

Indications and Usage

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

Dosage and Administration

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

Description

Relieves pain, crankiness and crying during teething

Section 34072-9

Caution: If symptoms persist or worsen, a health care professional should be consulted. Keep this and all medicines from the reach of children.

Section 34076-0

All Native Remedies health products are especially 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

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 50565-1

Keep this and all medicines from the reach of children.

Section 51727-6

Sucrose (inactive ingredient).

Section 51945-4

Section 55105-1

Relieves pain, crankiness and crying during teething


Structured Label Content

Warnings and Precautions (34071-1)

Contains no gluten, artificial flavors, colors or preservatives.Safe for all ages.

Active Ingredient (55106-9)

Ingredients: Each dose contains equal parts of Passiflora (3X) (HPUS), Chamomilla (3X) (HPUS), Calc fluor (6X) (HPUS), Calc phos (6X) (HPUS), Chamomilla (6C) (HPUS)

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Section 34072-9 (34072-9)

Caution: If symptoms persist or worsen, a health care professional should be consulted. Keep this and all medicines from the reach of children.

Section 34076-0 (34076-0)

All Native Remedies health products are especially 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

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 50565-1 (50565-1)

Keep this and all medicines from the reach of children.

Section 51727-6 (51727-6)

Sucrose (inactive ingredient).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Relieves pain, crankiness and crying during teething


Advanced Ingredient Data


Raw Label Data

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