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 
Speer Laboratories, LLC

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.

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Tranquil Remedy No. 11

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 Ingredients: Citric acid, Potassium sorbate, Purified water.

Uses: Temporarily relieves symptoms of:

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.

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.

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

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

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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55926-0011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE10 [hp_X]  in 59 mL
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA10 [hp_X]  in 59 mL
AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA10 [hp_X]  in 59 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE10 [hp_X]  in 59 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]  in 59 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]  in 59 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]  in 59 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 59 mL
CARBON MONOXIDE (UNII: 7U1EE4V452) (CARBON MONOXIDE - UNII:7U1EE4V452) CARBON MONOXIDE10 [hp_X]  in 59 mL
CARPINUS BETULUS FLOWERING TOP (UNII: QOI241B01F) (CARPINUS BETULUS FLOWERING TOP - UNII:QOI241B01F) CARPINUS BETULUS FLOWERING TOP10 [hp_X]  in 59 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID10 [hp_X]  in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS10 [hp_X]  in 59 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 59 mL
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) (EGG PHOSPHOLIPIDS - UNII:1Z74184RGV) EGG PHOSPHOLIPIDS10 [hp_X]  in 59 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE10 [hp_X]  in 59 mL
OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ) (OLEA EUROPAEA FLOWER - UNII:498M34P1VZ) OLEA EUROPAEA FLOWER10 [hp_X]  in 59 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID10 [hp_X]  in 59 mL
SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND10 [hp_X]  in 59 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM10 [hp_X]  in 59 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED10 [hp_X]  in 59 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55926-0011-259 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/17/2013
Labeler - Speer Laboratories, LLC (064900125)
Registrant - Speer Laboratories, LLC (064900125)
Establishment
NameAddressID/FEIBusiness Operations
King Bio Inc.617901350api manufacture(55926-0011)

Revised: 8/2013
Document Id: 8d7e21c4-e8c5-4d45-ba24-f7a9e0cf593c
Set id: 57e33245-7b8d-478b-b052-f960c75702c3
Version: 1
Effective Time: 20130801
 
Speer Laboratories, LLC