DIZZIFREE- bryonia, cocculus, gelsemium, lobelia inf spray

DizziFree by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

HPUS Active Ingredients

Each dose contains equal volumes of each ingredient in 30C potency: Bryonia, Cocculus, Gelsemium, Lobelia inf.

Uses

*Homeopathic remedy for the temporary symptom relief of dizziness and nausea. *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.

Directions

Before initial use, depress pump 4-5 times or until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily, as needed, or until symptoms improve. Adults: Take 3 sprays. Children 2-12: Take 2 sprays.

Other Information

Contains no artificial flavors or artificial colors. No gluten added. The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Tamper resistant for your protection. Use only if safety seal is intact.

INACTIVE INGREDIENT

Citric acid, potassium sorbate, purified water

KEEP OUT OF REACH OF CHILDREN

Keep this and all medication out of reach of children.

PREGNANCY OR BREAST FEEDING

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

PURPOSE

Temporarily relieves dizziness & nausea

INGREDIENTS AND APPEARANCE

DIZZIFREE 
bryonia, cocculus, gelsemium, lobelia inf spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-204
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	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
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	30 [hp_C]  in 59 mL
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U)	LOBELIA INFLATA	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: 68703-204-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/15/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/15/2016

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	api manufacture(68703-204) , manufacture(68703-204)