Label: FCS HP- epinephrine, glutamic acid, mucuna pruriens seed, niacinamide, serotonin, ubidecarenone, corticotropin, ascorbic acid, adenosine triphosphate, insulin pork, sus scrofa parathyroid gland, sus scrofa pituitary gland, thiamine hydrochloride, thyroid, anhydrous citric acid, herring sperm dna, saccharomyces cerevisiae rna, anacardium occidentale fruit, arsenic trioxide, aspartic acid, barium carbonate, oyster shell calcium carbonate crude, lycopodium clavatum spore, anemone pulsatilla, datura stramonium, sulfur liquid

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 2, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS - equal amounts of: Adrenalinum 8X, 12X, 30X, 6C, 12C, 30C,  L-Glutamic Acid 8X, 12X, 30X, 12C, 30C, Mucuna Pruriens 8X, 12X, 30X, 12C, 30C, Niacinamide 8X, Serotonin 8X, 12X, 30X, 12C, 30C, Ubiquinone 8X, ACTH 8X, 12X, 30X, 12C, 30C, Ascorbic Acid 6C, ATP 6C, Insulinum 6C, Parathyroidinum 6C, Pituitaria Glandula 6C, Thiaminum Hydrochloricum 6C, Thyroidinum 6C, Citricum Ac 12C, DNA 12C, RNA 12C, Anacardium Occ 30C, Arsenicum Alb 30C, Aspartic Acid 30C, Baryta Carb 30C, Calc Carb 30C, Lycopodium 30C, Pulsatilla 30C, Stramonium 30C, Sulphur 30C.

  • PURPOSE

    Uses: Helps restore mental alertness.**

  • INDICATIONS & USAGE

    Uses: Helps restore mental alertness.**

  • DOSAGE & ADMINISTRATION

    Directions:  Adults & children above 12 years:  10 drops orally 3 times daily, or as directed by a health care professional.

  • KEEP OUT OF REACH OF CHILDREN

    WARNINGS:

      *Consult a physician for use in children under 12 years of age.

      * IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

      * KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion)   get    medical help or contact a Poison Control Center right away.

  • WARNINGS

    WARNINGS:

      *Consult a physician for use in children under 12 years of age.

      * IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

      * KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion)   get    medical help or contact a Poison Control Center right away.

      * Do not use if TAMPER EVIDENT seal is broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Ethyl Alcohol USP, Purified Water.

  • QUESTIONS

    Questions & Comments? 

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

    ** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

    LOT:

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406–0617-1

    FCS HP

    Mental Alertness**

    HOMEOPATHIC

    1 fl oz (30 mL) / 20% Alcohol

    GMP Logo UPC: 877730004536 NON GMO Logo

    image description

  • INGREDIENTS AND APPEARANCE
    FCS HP 
    epinephrine, glutamic acid, mucuna pruriens seed, niacinamide, serotonin, ubidecarenone, corticotropin, ascorbic acid, adenosine triphosphate, insulin pork, sus scrofa parathyroid gland, sus scrofa pituitary gland, thiamine hydrochloride, thyroid, anhydrous citric acid, herring sperm dna, saccharomyces cerevisiae rna, anacardium occidentale fruit, arsenic trioxide, aspartic acid, barium carbonate, oyster shell calcium carbonate crude, lycopodium clavatum spore, anemone pulsatilla, datura stramonium, sulfur liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43406-0617
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE30 [hp_C]  in 1 mL
    GLUTAMIC ACID (UNII: 3KX376GY7L) (GLUTAMIC ACID - UNII:3KX376GY7L) GLUTAMIC ACID30 [hp_C]  in 1 mL
    MUCUNA PRURIENS SEED (UNII: 55G8SQ543S) (MUCUNA PRURIENS SEED - UNII:55G8SQ543S) MUCUNA PRURIENS SEED30 [hp_C]  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE8 [hp_X]  in 1 mL
    SEROTONIN (UNII: 333DO1RDJY) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN30 [hp_C]  in 1 mL
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE8 [hp_X]  in 1 mL
    CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN30 [hp_C]  in 1 mL
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID6 [hp_C]  in 1 mL
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE6 [hp_C]  in 1 mL
    INSULIN PORK (UNII: AVT680JB39) (INSULIN PORK - UNII:AVT680JB39) INSULIN PORK6 [hp_C]  in 1 mL
    SUS SCROFA PARATHYROID GLAND (UNII: 2KBE35NE8S) (SUS SCROFA PARATHYROID GLAND - UNII:2KBE35NE8S) SUS SCROFA PARATHYROID GLAND6 [hp_C]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T) SUS SCROFA PITUITARY GLAND6 [hp_C]  in 1 mL
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE6 [hp_C]  in 1 mL
    THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED6 [hp_C]  in 1 mL
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID12 [hp_C]  in 1 mL
    HERRING SPERM DNA (UNII: 51FI676N6F) (HERRING SPERM DNA - UNII:51FI676N6F) HERRING SPERM DNA12 [hp_C]  in 1 mL
    SACCHAROMYCES CEREVISIAE RNA (UNII: J17GBZ5VGX) (SACCHAROMYCES CEREVISIAE RNA - UNII:J17GBZ5VGX) SACCHAROMYCES CEREVISIAE RNA12 [hp_C]  in 1 mL
    ANACARDIUM OCCIDENTALE FRUIT (UNII: 4A10JR4E7E) (ANACARDIUM OCCIDENTALE FRUIT - UNII:4A10JR4E7E) ANACARDIUM OCCIDENTALE FRUIT30 [hp_C]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_C]  in 1 mL
    ASPARTIC ACID (UNII: 30KYC7MIAI) (ASPARTIC ACID - UNII:30KYC7MIAI) ASPARTIC ACID30 [hp_C]  in 1 mL
    BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CATION30 [hp_C]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA30 [hp_C]  in 1 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM30 [hp_C]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0617-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2016
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0617)