TRANQUIL REMEDY NO. 11- adrenalinum, alfalfa, ambrosia artemisiaefolia, anacardium orientale, argentum nitricum, avena sativa, aesculus hippocastanum, flos, calcarea carbonica, carboneum oxygenisatum, carpinus betulus, flos, citricum acidum, gelsemium sempervirens, hypothalamus, kali phosphoricum, lecithin, natrum muriaticum, olea europaea, flos, phosphoricum acidum, pituitarum posterium, selenium metallicum, sepia, silicea, thyroidinum liquid

Tranquil Remedy No. 11 by

Drug Labeling and Warnings

Tranquil Remedy No. 11 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: Adrenalinum, Alfalfa, Ambrosia artemisiaefolia, Anacardium orientale, Argentum nitricum, Avena sativa, Aesculus hippocastanum, flos, Calcarea carbonica, Carboneum oxygenisatum, Carpinus betulus, flos, Citricum acidum, Gelsemium sempervirens, Hypothalamus, Kali phosphoricum, Lecithin, Natrum muriaticum, Olea europaea, flos, Phosphoricum acidum, Pituitarum posterium, Selenium metallicum, Sepia, Silicea, Thyroidinum.

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:

• mental or physical burnout
• nervousness
• nervous exhaustion
• fatigue
• lack of focus
• weak memory
• irritability
• confusion
• indifference
• ADD/ADHD

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

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

PURPOSE

Uses: Temporarily relieves symptoms of: mental or physical burnout, nervousness, nervous exhaustion, fatigue, lack of focus, weak memory, irritability, confusion, indifference, ADD/ADHD.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRANQUIL REMEDY NO. 11 
adrenalinum, alfalfa, ambrosia artemisiaefolia, anacardium orientale, argentum nitricum, avena sativa, aesculus hippocastanum, flos, calcarea carbonica, carboneum oxygenisatum, carpinus betulus, flos, citricum acidum, gelsemium sempervirens, hypothalamus, kali phosphoricum, lecithin, natrum muriaticum, olea europaea, flos, phosphoricum acidum, pituitarum posterium, selenium metallicum, sepia, silicea, thyroidinum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55926-0011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	10 [hp_X]  in 59 mL
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD)	ALFALFA	10 [hp_X]  in 59 mL
AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A)	AMBROSIA ARTEMISIIFOLIA	10 [hp_X]  in 59 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU)	SEMECARPUS ANACARDIUM JUICE	10 [hp_X]  in 59 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	10 [hp_X]  in 59 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	10 [hp_X]  in 59 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	10 [hp_X]  in 59 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	10 [hp_X]  in 59 mL
CARBON MONOXIDE (UNII: 7U1EE4V452) (CARBON MONOXIDE - UNII:7U1EE4V452)	CARBON MONOXIDE	10 [hp_X]  in 59 mL
CARPINUS BETULUS FLOWERING TOP (UNII: QOI241B01F) (CARPINUS BETULUS FLOWERING TOP - UNII:QOI241B01F)	CARPINUS BETULUS FLOWERING TOP	10 [hp_X]  in 59 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	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
BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7)	BOS TAURUS HYPOTHALAMUS	10 [hp_X]  in 59 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	10 [hp_X]  in 59 mL
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) (EGG PHOSPHOLIPIDS - UNII:1Z74184RGV)	EGG PHOSPHOLIPIDS	10 [hp_X]  in 59 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	10 [hp_X]  in 59 mL
OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ) (OLEA EUROPAEA FLOWER - UNII:498M34P1VZ)	OLEA EUROPAEA FLOWER	10 [hp_X]  in 59 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	10 [hp_X]  in 59 mL
SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T)	SUS SCROFA PITUITARY GLAND	10 [hp_X]  in 59 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	10 [hp_X]  in 59 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	10 [hp_X]  in 59 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	10 [hp_X]  in 59 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P)	THYROID, UNSPECIFIED	10 [hp_X]  in 59 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55926-0011-2	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(55926-0011)