Label: FATIGUE FORMULA (medulla ossis suis, spleen (bovine), thymus (ovine), carcinosin, cytomegalovirus nosode, influenzinum- 2022-2023, streptococcus viridans, toxoplasma gondii, epstein-bar virus nosode spray

  • NDC Code(s): 83027-0125-1
  • Packager: Nutritional Specialties, Inc.
  • 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 November 16, 2023

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  • ACTIVE INGREDIENTS:

    Medulla Ossis Suis 6X, 12X, 30X, Spleen 6X, 12X, 30X, Thymus 6X, 12X, 30X, Carcinosin 16X, 24X, 30X, 100X, Cytomegalovirus Nosode 16X, 24X, 30X, 100X, Influenzinum 16X, 24X, 30X, 100X, Streptococcus Viridans 16X, 24X, 30X, 100X, Toxoplasma Gondii 16X, 24X, 30X, 100X, Epstein-Bar Virus Nosode 16C, 24C, 30C, 100C.

  • PURPOSE:

    Assists in temporary relief of fatigue and headaches.†

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

  • WARNINGS:

    Professional Use Only

    If pregnant or breast-feeding, ask a health professional before use.

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

    If condition worsens, seek medical attention.

    KEEP OUT OF REACH OF CHILDREN

    Do not use if tamper evident seal is broken or missing.

    Store in a cool place after opening

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    Assists in temporary relief of fatigue and headaches.†

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

  • INACTIVE INGREDIENTS:

    Alcohol USP 20%, Purified Water USP.

  • QUESTIONS:

    MANUFACTURED EXCLUSIVELY FOR

    NUTRITIONAL SPECIALTIES, INC.

    PO BOX 97227

    PITTSBURG, PA 15229

    www.phpltd.com

  • PACKAGE LABEL DISPLAY:

    Professional

    Health Products

    HOMEOPATHIC

    NDC 83027-0125-1

    FATIGUE

    FORMULA

    2 FL. OZ (60 ml)

    FATIGUE FORMULA

  • INGREDIENTS AND APPEARANCE
    FATIGUE FORMULA 
    medulla ossis suis, spleen (bovine), thymus (ovine), carcinosin, cytomegalovirus nosode, influenzinum (2022-2023), streptococcus viridans, toxoplasma gondii, epstein-bar virus nosode spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83027-0125
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8) SUS SCROFA BONE MARROW6 [hp_X]  in 1 mL
    BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN6 [hp_X]  in 1 mL
    LAMB (UNII: FOF26T73HA) (LAMB - UNII:FOF26T73HA) LAMB6 [hp_X]  in 1 mL
    HUMAN BREAST TUMOR CELL (UNII: C62OO7VD9K) (HUMAN BREAST TUMOR CELL - UNII:C62OO7VD9K) HUMAN BREAST TUMOR CELL16 [hp_X]  in 1 mL
    HUMAN HERPESVIRUS 5 (UNII: 7COI029E6K) (HUMAN HERPESVIRUS 5 - UNII:7COI029E6K) HUMAN HERPESVIRUS 516 [hp_X]  in 1 mL
    INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (UNII: 34C49NV47P) (INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - UNII:NGL844Y7X6) INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)16 [hp_X]  in 1 mL
    INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (UNII: P483J7GX6D) (INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - UNII:GRN94TP8YV) INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)16 [hp_X]  in 1 mL
    INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (UNII: TBV2PPG6EF) (INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - UNII:28EAH8253X) INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)16 [hp_X]  in 1 mL
    INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED) (UNII: H2198F8ZNA) (INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - UNII:3VSF1BF3SR) INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)16 [hp_X]  in 1 mL
    STREPTOCOCCUS VIRIDANS GROUP (UNII: NNV2379HKR) (STREPTOCOCCUS VIRIDANS GROUP - UNII:NNV2379HKR) STREPTOCOCCUS VIRIDANS GROUP16 [hp_X]  in 1 mL
    TOXOPLASMA GONDII (UNII: BMV90JF469) (TOXOPLASMA GONDII - UNII:BMV90JF469) TOXOPLASMA GONDII16 [hp_X]  in 1 mL
    HUMAN HERPESVIRUS 4 (UNII: 2A26YW7PNX) (HUMAN HERPESVIRUS 4 - UNII:2A26YW7PNX) HUMAN HERPESVIRUS 416 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83027-0125-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/10/2023
    Labeler - Nutritional Specialties, Inc. (032744609)
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