ORAL SOOTHE- passiflora, chamomilla, calc fluor, calc phos, chamomilla granule

Oral Soothe by

Drug Labeling and Warnings

Oral Soothe by is a Homeopathic medication manufactured, distributed, or labeled by Feelgood Health, W. Last. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Relieves pain, crankiness and crying during teething

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

GENERAL PRECAUTIONS

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

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)

INACTIVE INGREDIENT

Sucrose (inactive ingredient).

WARNINGS

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

INFORMATION FOR PATIENTS

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.

PRINCIPAL DISPLAY PANEL

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines from the reach of children.

INGREDIENTS AND APPEARANCE

ORAL SOOTHE 
passiflora, chamomilla, calc fluor, calc phos, chamomilla granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68647-165
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA TOP	3 [hp_X]  in 40 mg
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]  in 40 mg
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM FLUORIDE	6 [hp_X]  in 40 mg
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) (CALCIUM CATION - UNII:2M83C4R6ZB)	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	6 [hp_X]  in 40 mg
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_C]  in 40 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)	20000 mg  in 20000 mg

Product Characteristics
Color	white (white sucrose granules)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68647-165-10	20000 mg in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2010

Labeler - Feelgood Health (538418296)

Establishment
Name	Address	ID/FEI	Business Operations
W. Last		567284153	manufacture