RESPOSOOTHE- aconitum napellus, arsenicum album, bryonia, cuprum metallicum, phosphorus spray

RespoSoothe by

Drug Labeling and Warnings

RespoSoothe by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HPUS Active Ingredients:

Equal volumes of each ingredient: Aconitum napellus 30C, Arsenicum album 30C, Bryonia 30C, Cuprum metallicum 30C, Phosphorus 6C.

Uses*:

For temporary relief of tight chest, wheezing, & chest congestion associated with colds & seasonal allergies.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings:

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed or until symptoms improve. Adults: Take 3 pump sprays. Children under 12: Take 2 pump sprays.

OTHER SAFETY INFORMATION

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 mroe information, visit us at www.nativeremedies.com.

Contains no artificial flavors or colorants. No gluten added.

Inactive Ingredients:

Citric acid, potassium sorbate, purified water.

KEEP OUT OF REACH OF CHILDREN

Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

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

PURPOSE

Temporarily relieves tight chest, wheezing, & chest congestion associated with colds & seasonal allergies

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RESPOSOOTHE 
aconitum napellus, arsenicum album, bryonia, cuprum metallicum, phosphorus spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-262
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	30 [hp_C]  in 59 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC CATION (3+)	30 [hp_C]  in 59 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_C]  in 59 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	30 [hp_C]  in 59 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	30 [hp_C]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-262-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/24/2016

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	api manufacture(68703-262) , manufacture(68703-262)