Label: PINEAL FORMULA- betula pendula folia, castanea vesca, poplar bud, rna, sus scrofa pineal gland solution/ drops

  • Category: HUMAN OTC 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 January 8, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients

    Betula Pendula, Folia

    2X

    Castanea Vesca

    2X

    Poplar Bud

    2X

    RNA

    3X 4X

    Sus Scrofa Pineal Gland

    4C 7C
  • INDICATIONS & USAGE

    Uses:

    For temporary relief of minor:

    fatigue*

    headache*
    sleeplessness*

    nausea*
    irritability*

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • Warnings:

    If pregnant or breastfeeding, ask a health professional before use.

    Do not use if clear seal over the cap is broken or missing.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if fatigue, headache,sleeplessness, nausea, irritability, or other symptoms do not improve within 7 days or are accompanied by fever.

  • Directions:

    Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

  • Inactive Ingredients

    alcohol (20% by volume), distilled water

  • QUESTIONS

    Distributed by Apex Energetics. Questions?
    16592 Hale Ave., Irvine, CA 92606, USA

  • PRINCIPAL DISPLAY PANEL

    The Younger You®

    Dr. Galitzer’s

    PINEAL

    Formula

    Fatigue*

    Headache*

    Sleeplessness*

    Homeopathic Formula

    1 fl oz (30 mL)

    Alcohol 20% by Volume

    YY07-220926

  • INGREDIENTS AND APPEARANCE
    PINEAL FORMULA 
    betula pendula folia, castanea vesca, poplar bud, rna, sus scrofa pineal gland solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63479-2507
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POPULUS BALSAMIFERA LEAF BUD (UNII: 9CQ6C00G3C) (POPULUS BALSAMIFERA LEAF BUD - UNII:9CQ6C00G3C) POPULUS BALSAMIFERA LEAF BUD2 [hp_X]  in 1 mL
    SACCHAROMYCES CEREVISIAE RNA (UNII: J17GBZ5VGX) (SACCHAROMYCES CEREVISIAE RNA - UNII:J17GBZ5VGX) SACCHAROMYCES CEREVISIAE RNA4 [hp_X]  in 1 mL
    BETULA PENDULA LEAF (UNII: 5HW39H9KDH) (BETULA PENDULA LEAF - UNII:5HW39H9KDH) BETULA PENDULA LEAF2 [hp_X]  in 1 mL
    SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7) SUS SCROFA PINEAL GLAND7 [hp_C]  in 1 mL
    CASTANEA SATIVA LEAF (UNII: IV3S2HH53G) (CASTANEA SATIVA LEAF - UNII:IV3S2HH53G) CASTANEA SATIVA LEAF2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63479-2507-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/17/2022
    Labeler - Apex Energetics Inc. (195816384)
    Registrant - Apex Energetics Inc. (195816384)
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