RELAXATONE- passiflora incarnata, scutellaria lateriflora, valeriana officinalis, arsenicum album, calcarea carbonica, coffea cruda, ignatia amara, kali phosphoricum lycopus virginicus, staphysagria liquid

Relaxatone by

Drug Labeling and Warnings

Relaxatone by is a Homeopathic medication manufactured, distributed, or labeled by Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:  Passiflora incarnata 3X, Scutellaria lateriflora 3X, Valeriana officinalis 3X, Arsenicum album 12X, Calcarea carbonica 12X, Coffea cruda 12X, Ingatia amara 12X, Kali phosphoricum 12X, Lycopus virginicus 12X, Staphysagria 12X.

PURPOSE

INDICATIONS:  For temporary relief of anxiety and stress.

WARNINGS

WARNINGS:  If pregnant or breast-feeding, ask a health professional before use.

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

Do not use if tamper evident seal is broken or missing.  Store in a cool, dry place.

DOSAGE & ADMINISTRATION

SUGGESTED USE:  Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.  If symptoms persist, consult your health care professional.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:  Demineralized water, 20% Ethanol.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.   In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

INDICATIONS:  For temporary relief of anxiety and stress.

QUESTIONS

Dist by  Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

PRINCIPAL DISPLAY PANEL

ENERGIQUE

RELAXATONE

Homeopathic Remedy

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

RELAXATONE 
passiflora incarnata, scutellaria lateriflora, valeriana officinalis, arsenicum album, calcarea carbonica, coffea cruda, ignatia amara, kali phosphoricum lycopus virginicus, staphysagria liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0304
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 1 mL
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC)	SCUTELLARIA LATERIFLORA	3 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	12 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X]  in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM PHOSPHATE, DIBASIC	12 [hp_X]  in 1 mL
LYCOPUS VIRGINICUS (UNII: TWH5125Q6F) (LYCOPUS VIRGINICUS - UNII:TWH5125Q6F)	LYCOPUS VIRGINICUS	12 [hp_X]  in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	12 [hp_X]  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: 57520-0304-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/11/2010

Labeler - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture