Label: HEILEN (galium aparine, agnus castus, apis mellifica, capsicum annuum, chelidonium majus, taraxacum officinale, urtica dioica, xanthoxylum fraxineum, fucus vesiculosus, kali phosphoricum, magnesia phosphorica, natrum phosphoricum, sarsaparilla (smilax regelii), ubidecarenonum, calcarea carbonica, graphites, lycopodium clavatum, anacardium orientale, colchicum autumnale, nux vomica, phytolacca decandra, pulsatilla- pratensis, histaminum hydrochloricum liquid
- NDC Code(s): 70719-0003-1
- Packager: Heilen
- 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 January 21, 2022
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ACTIVE INGREDIENTS:
Galium Aparine 3X, Agnus Castus 6X, Apis Mellifica 6X, Capsicum Annuum 6X, Chelidonium Majus 6X, Taraxacum Officinale 6X, Urtica Dioica 6X, Xanthoxylum Fraxineum 6X, Fucus Vesiculosus 6X, 12X, 30X, Kali Phosphoricum 12X, Magnesia Phosphorica 12X, Natrum Phosphoricum12X, Sarsaparilla (Smilax Regelii) 12X, Ubidecarenonum 12X, Calcarea Carbonica 12X, 30X, 60X, Graphites 12X, 30X, 60X, Lycopodium Clavatum 12X, 30X, 60X, Anacardium Orientale 30C, Colchicum Autumnale 30C, Nux Vomica 30C, Phytolacca Decandra 30C, Pulsatilla (Pratensis) 30C, Histaminum Hydrochloricum 200C.
- HOMEOPATHIC INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
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DIRECTIONS:
1-12 drops under the tongue, 3 times a day or as directed by your health professional. Avoid eating and/or drinking 15 minutes or longer before or after taking. Consult a physician for use in children under 12 years of age. Do not touch dropper to lips, teeth, or tongue to avoid contamination. Keep lid tightly closed when not in use.
- HOMEOPATHIC INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
HEILEN
galium aparine, agnus castus, apis mellifica, capsicum annuum, chelidonium majus, taraxacum officinale, urtica dioica, xanthoxylum fraxineum, fucus vesiculosus, kali phosphoricum, magnesia phosphorica, natrum phosphoricum, sarsaparilla (smilax regelii), ubidecarenonum, calcarea carbonica, graphites, lycopodium clavatum, anacardium orientale, colchicum autumnale, nux vomica, phytolacca decandra, pulsatilla (pratensis), histaminum hydrochloricum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70719-0003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GALIUM APARINE WHOLE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE WHOLE 3 [hp_X] in 1 mL CHASTE TREE FRUIT (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE FRUIT 6 [hp_X] in 1 mL APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 6 [hp_X] in 1 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 6 [hp_X] in 1 mL CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE 6 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 6 [hp_X] in 1 mL URTICA DIOICA WHOLE (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA WHOLE 6 [hp_X] in 1 mL ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK 6 [hp_X] in 1 mL FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS 6 [hp_X] in 1 mL DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE 12 [hp_X] in 1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X] in 1 mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 12 [hp_X] in 1 mL SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT 12 [hp_X] in 1 mL UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE 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 GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 12 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 12 [hp_X] in 1 mL SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE 30 [hp_C] in 1 mL COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB 30 [hp_C] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 30 [hp_C] in 1 mL PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE 30 [hp_C] in 1 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 200 [hp_C] 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:70719-0003-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/21/2022 Labeler - Heilen (080246141)
