Label: 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

  • Category: HUMAN OTC DRUG LABEL

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 Label Information

Updated August 1, 2013

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  • 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

    image description

  • 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 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)
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