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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Relaxatone

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.

INDICATIONS:  For temporary relief of anxiety and stress.


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.


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 INGREDIENTS:  Demineralized water, 20% Ethanol.


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


INDICATIONS:  For temporary relief of anxiety and stress.


Dist by  Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800-869-8078

ENERGIQUE

RELAXATONE

Homeopathic Remedy

1 fl. oz. (30 ml)

Relaxatone

Relaxatone

RELAXATONE 
passiflora incarnata, scutellaria lateriflora, valeriana officinalis, arsenicum album, calcarea carbonica, coffea cruda, ignatia amara, kali phosphoricum lycopus virginicus, staphysagria liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0304
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP3 [hp_X]  in 1 mL
SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA3 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN12 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_X]  in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC12 [hp_X]  in 1 mL
LYCOPUS VIRGINICUS (UNII: TWH5125Q6F) (LYCOPUS VIRGINICUS - UNII:TWH5125Q6F) LYCOPUS VIRGINICUS12 [hp_X]  in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57520-0304-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/11/201009/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/11/201009/10/2022
Labeler - Apotheca Company (844330915)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(57520-0304) , api manufacture(57520-0304) , label(57520-0304) , pack(57520-0304)

Revised: 4/2022
Document Id: f5721edf-f559-4da2-a1d6-22ee22e81427
Set id: 336e1df1-bd90-4e2d-98f7-03940dff0809
Version: 2
Effective Time: 20220401
 
Apotheca Company