Label: RELAXATONE- passiflora incarnata, scutellaria lateriflora, valeriana officinalis, arsenicum album, calcarea carbonica, coffea cruda liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 44911-0077-1 - Packager: Energique, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 12, 2021
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
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- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
RELAXATONE
passiflora incarnata, scutellaria lateriflora, valeriana officinalis, arsenicum album, calcarea carbonica, coffea cruda liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0077 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING 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 CATION (3+) - UNII:C96613F5AV) 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) (PHOSPHATE ION - UNII:NK08V8K8HR) 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:44911-0077-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 04/12/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/12/2013 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0077)