SINUS SOOTHE- kali bich, pulsatilla, hepar sulph, thuja occ, spigelia anth tincture

Sinus Soothe by

Drug Labeling and Warnings

Sinus Soothe by is a Homeopathic medication manufactured, distributed, or labeled by Native Remedies, LLC, Vitality Works, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Relieves sinus congestion, pain and headache

ACTIVE INGREDIENT

Active Ingredients: Each dose contains equal parts of: Kali bich 6C HPUS, Pulsatilla 6C HPUS, Hepar sulph 6C HPUS, Thuja occ, Spigelia anth 6C HPUS

INDICATIONS & USAGE

Uses: Homeopathic remedy to relieve the symptoms of sinusitis

WARNINGS

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

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep this and all medication out of reach  of children

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

Directions:For all ages: Mix 0.50 mL in 1/4 cup of water and sip slowly. Repeat every 2 hours until symptoms subside

INACTIVE INGREDIENT

Inactive Ingredients: USP Purified water, grain alcohol (20% by volume)

INFORMATION FOR PATIENTS

The letters HPUS indicate that the component in this product are oficically monographed in the Homeopathic Pharmacopoeia of the United States

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

Contains no animal products, gluten, artificial flavors, preservatives or colorants. Suitable for vegetarians and safe for all ages

STORAGE AND HANDLING

Tamper resistant for you protection. Use only if safety seal is intact

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINUS SOOTHE 
kali bich, pulsatilla, hepar sulph, thuja occ, spigelia anth tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-093
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_C]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_C]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_C]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	12 [hp_C]  in 1 mL
Spigelia Anthelmia (UNII: WYT05213GE) (Spigelia Anthelmia - UNII:WYT05213GE)	Spigelia Anthelmia	6 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-093-59	59 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/08/2013

Labeler - Native Remedies, LLC (192014186)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works, Inc		137752817	manufacture(68703-093) , api manufacture(68703-093)