SOOTHE REMEDY NO. 20- belladonna, bryonia, capsicum annuum, chininum arsenicosum, coffea cruda, gelsemium sempervirens, glonoinum, ignatia amara, kali bichromicum, lycopodium clavatum, natrum muriaticum, nux vomica, sanguinaria canadensis, spigelia anthelmia, sulphur liquid

Soothe Remedy No. 20 by

Drug Labeling and Warnings

Soothe Remedy No. 20 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 Ingredients HPUS: Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur.

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

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

INACTIVE INGREDIENT

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

INDICATIONS & USAGE

Uses: Temporarily relieves symptoms of:

• headache pain (throbbing, splitting, tight, dull, sick, bursting, sinus, congestive, migraine, occiptal, etc)
• band feeling around the head
• morning headache
• sun headache

DOSAGE & ADMINISTRATION

Directions:

Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. For adults only.  Adult dose 3 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

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

PURPOSE

Uses: Temporarily relieves symptoms of: headache pain (throbbing, splitting, tight, dull, sick, bursting, sinus, congestive, migraine, occipital, etc), band feeling around the head, morning headache, sun headache.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOOTHE REMEDY NO. 20 
belladonna, bryonia, capsicum annuum, chininum arsenicosum, coffea cruda, gelsemium sempervirens, glonoinum, ignatia amara, kali bichromicum, lycopodium clavatum, natrum muriaticum, nux vomica, sanguinaria canadensis, spigelia anthelmia, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55926-0020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	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
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	10 [hp_X]  in 59 mL
QUININE ARSENITE (UNII: 42QO5P0NLM) (QUININE - UNII:A7V27PHC7A)	QUININE ARSENITE	10 [hp_X]  in 59 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	10 [hp_X]  in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	10 [hp_X]  in 59 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	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
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	10 [hp_X]  in 59 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	10 [hp_X]  in 59 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	10 [hp_X]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	10 [hp_X]  in 59 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	10 [hp_X]  in 59 mL
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	10 [hp_X]  in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	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: 55926-0020-2	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(55926-0020)