SERENITY REMEDY NO. 12- aconitum napellus, apis mellifica, arnica montana, arsenicum album, belladonna, bellis perennis, bryonia, calendula officinalis, chamomilla, clematis erecta, clematis vitalba, flos, ferrum phosphoricum, histaminum hydrochloricum, hypericum perforatum, ignatia amara, impatiens glandulifera, flos, ornithogalum umbellatum, flos, passiflora incarnata, phosphorus, prunus cerasifera, flos, rhus toxicodendron, sulphur, symphytum officinale, veratrum album liquid

Serenity Remedy No. 12 by

Drug Labeling and Warnings

Serenity Remedy No. 12 by is a Homeopathic medication manufactured, distributed, or labeled by Speer Laboratories, LLC, King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient HPUS:  Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, symphytum officinale, Veratrum album.

Equal volumes of each ingredient in: 10X, 30X, LM1 potencies.

HPUS indicates that this ingredient is officially part of the Homeopathic Pharmacopia of the United States.

INACTIVE INGREDIENT

Inactive Ingredients: Citric acid, Potassium sorbate, Purified water.

INDICATIONS & USAGE

Uses: Temporarily relieves symptoms of:

• mental, physical or emotional stress
• tension
• apathy
• oversensitivity
• body pains
• nervousness
• irritability
• fearfulness
• sleepessness

DOSAGE & ADMINISTRATION

Directions: Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. Adult Dose: 3 pump sprays. Children 2-12 years: 2 pump sprays.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS

Warnings:

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. If pregnant or breastfeeding, consult a doctor before use.

OTHER SAFETY INFORMATION

Other Information: Tamper resistant for your protection. Use only if safety seal is still intact.

PURPOSE

Uses: Temporarily relieves symptoms of: mental, physical or emotional stress, tension, apathy, oversensitivity, body pains, nervousness, irritability, fearfulness, sleepessness

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SERENITY REMEDY NO. 12 
aconitum napellus, apis mellifica, arnica montana, arsenicum album, belladonna, bellis perennis, bryonia, calendula officinalis, chamomilla, clematis erecta, clematis vitalba, flos, ferrum phosphoricum, histaminum hydrochloricum, hypericum perforatum, ignatia amara, impatiens glandulifera, flos, ornithogalum umbellatum, flos, passiflora incarnata, phosphorus, prunus cerasifera, flos, rhus toxicodendron, sulphur, symphytum officinale, veratrum album liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55926-0012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	10 [hp_X]  in 59 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	10 [hp_X]  in 59 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	10 [hp_X]  in 59 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X]  in 59 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	10 [hp_X]  in 59 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	10 [hp_X]  in 59 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X]  in 59 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	10 [hp_X]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	10 [hp_X]  in 59 mL
CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F)	CLEMATIS RECTA FLOWERING TOP	10 [hp_X]  in 59 mL
CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI)	CLEMATIS VITALBA FLOWER	10 [hp_X]  in 59 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	10 [hp_X]  in 59 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	10 [hp_X]  in 59 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	10 [hp_X]  in 59 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	10 [hp_X]  in 59 mL
IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV)	IMPATIENS GLANDULIFERA FLOWER	10 [hp_X]  in 59 mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP (UNII: CZD6M4PY4B) (ORNITHOGALUM UMBELLATUM FLOWERING TOP - UNII:CZD6M4PY4B)	ORNITHOGALUM UMBELLATUM FLOWERING TOP	10 [hp_X]  in 59 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	10 [hp_X]  in 59 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	10 [hp_X]  in 59 mL
PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS)	PRUNUS CERASIFERA FLOWER	10 [hp_X]  in 59 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	10 [hp_X]  in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 [hp_X]  in 59 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	10 [hp_X]  in 59 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55926-0012-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/17/2013

Labeler - Speer Laboratories, LLC (064900125)

Registrant - Speer Laboratories, LLC (064900125)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	api manufacture(55926-0012)