FDA.reportPublic FDA data

Fatigue Formula

Manufacturer
Nutritional Specialties, Inc.
Effective date
2023-11-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:24:53

Label at a glance#

ProductFatigue Formula
Active ingredientSUS SCROFA BONE MARROW, BOS TAURUS SPLEEN, BOS TAURUS THYMUS, HUMAN BREAST TUMOR CELL, HUMAN HERPESVIRUS 5, INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED), STREPTOCOCCUS VIRIDANS GROUP, TOXOPLASMA GONDII, HUMAN HERPESVIRUS 4
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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:

OTC - PURPOSE SECTION

Assists in temporary relief of fatigue and headaches.†

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

WARNINGS:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

Assists in temporary relief of fatigue and headaches.†

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Alcohol USP 20%, Purified Water USP.

QUESTIONS:

OTC - QUESTIONS SECTION

MANUFACTURED EXCLUSIVELY FOR

NUTRITIONAL SPECIALTIES, INC.

PO BOX 97227

PITTSBURG, PA 15229

www.phpltd.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional

Health Products

HOMEOPATHIC

NDC 83027-0022-1

FATIGUE

FORMULA

2 FL. OZ (60 ml)

FATIGUE FORMULAFATIGUE FORMULA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0022-1Fatigue Formula60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0022FATIGUE FORMULA (MEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (BOVINE), CARCINOSIN, CYTOMEGALOVIRUS NOSODE, INFLUENZINUM (2022-2023), STREPTOCOCCUS VIRIDANS, TOXOPLASMA GONDII, EPSTEIN-BAR VIRUS NOSODE) SPRAY [NUTRITIONAL SPECIALTIES, INC.]2Current NDC, 1 package rows20231117_eaec858d-6a86-403a-b07b-62d7bd4fca4a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83027-002283027-0022-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUS SCROFA BONE MARROWVP2CN2G7Y8ACTIB
BOS TAURUS SPLEEN190Q9MB3U3ACTIB
BOS TAURUS THYMUS8XEJ88V2T8ACTIB
HUMAN BREAST TUMOR CELLC62OO7VD9KACTIB
HUMAN HERPESVIRUS 57COI029E6KACTIB
INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)34C49NV47PACTIB
INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED)P483J7GX6DACTIB
INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)TBV2PPG6EFACTIB
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)H2198F8ZNAACTIB
STREPTOCOCCUS VIRIDANS GROUPNNV2379HKRACTIB
TOXOPLASMA GONDIIBMV90JF469ACTIB
HUMAN HERPESVIRUS 42A26YW7PNXACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fatigue FormulaMEDULLA OSSIS SUIS, SPLEEN (BOVINE), THYMUS (BOVINE), CARCINOSIN, CYTOMEGALOVIRUS NOSODE, INFLUENZINUM (2022-2023), STREPTOCOCCUS VIRIDANS, TOXOPLASMA GONDII, EPSTEIN-BAR VIRUS NOSODENutritional Specialties, Inc.eaec858d-6a86-403a-b07b-62d7bd4fca4a2023-11-16WarningsExact identifier
ndc (package): 83027-0022-1
ndc (product): 83027-0022
ndc11 (package): 83027002201
spl id: 59857a8f-c5a9-4c50-9fab-a9b643958df6
spl set id: eaec858d-6a86-403a-b07b-62d7bd4fca4a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.