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 
Heilen

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 FACTS:

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:

For temporary relief of symptoms related to increased appetite, regulation of fat metabolism, sluggish metabolism, headache, and fatigue.**

**These statements are based upon homeopathic principles. They have not been approved by the Food and Drug Administration.

WARNINGS:

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

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

Tamper seal: Sealed for Your Protection. Do not use if seal is broken or missing.

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.

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:

For temporary relief of symptoms related to increased appetite, regulation of fat metabolism, sluggish metabolism, headache, and fatigue.**

**These statements are based upon homeopathic principles. They have not been approved by the Food and Drug Administration.

INACTIVE INGREDIENTS:

demineralized water, 20% ethanol

QUESTIONS:

Distributed by Heilen

Brentwood, MO 63144

888-305-1412 • www.goheilen.com

PACKAGE LABEL DISPLAY:

        +plus

Heilen 

HOMEOPATHIC FORMULA

1 FL OZ (30 ml)

Heilen

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70719-0003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GALIUM APARINE WHOLE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE WHOLE3 [hp_X]  in 1 mL
CHASTE TREE FRUIT (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE FRUIT6 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM6 [hp_X]  in 1 mL
CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE6 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE6 [hp_X]  in 1 mL
URTICA DIOICA WHOLE (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA WHOLE6 [hp_X]  in 1 mL
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK6 [hp_X]  in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS6 [hp_X]  in 1 mL
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE12 [hp_X]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE12 [hp_X]  in 1 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT12 [hp_X]  in 1 mL
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE12 [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
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE30 [hp_C]  in 1 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB30 [hp_C]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT30 [hp_C]  in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE30 [hp_C]  in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE200 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70719-0003-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/21/2022
Labeler - Heilen (080246141)

Revised: 1/2022
Document Id: 5b132501-f52a-410c-b606-b6142568bcd1
Set id: ef3f66f9-47bc-4fce-8950-ed2319bc30d6
Version: 1
Effective Time: 20220121
 
Heilen