MedPath

STRESS / FATIGUE

STRESS / FATIGUE

Approved
Approval ID

2ab1ac84-e233-4c54-a128-a3400e13e7ca

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 2, 2025

Manufacturers
FDA

Natural Creations, Inc.

DUNS: 018022074

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Adrenalinum, Pituitarum Gland, Thyroidinum, Arsenicum Alb, Calc Carb, Conium, Cortisone Aceticum, Crotalus Hor, Ferrum Met, Nux Vomica, Phosphoricum Ac, Phosphorus, Selenium, Sepia, Xanthoxylum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43406-0695
Product Classification
G
Generic Name
Adrenalinum, Pituitarum Gland, Thyroidinum, Arsenicum Alb, Calc Carb, Conium, Cortisone Aceticum, Crotalus Hor, Ferrum Met, Nux Vomica, Phosphoricum Ac, Phosphorus, Selenium, Sepia, Xanthoxylum
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2025
FDA Product Classification

INGREDIENTS (17)

EPINEPHRINEActive
Quantity: 9 [hp_X] in 1 mL
Code: YKH834O4BH
Classification: ACTIB
SUS SCROFA PITUITARY GLAND, POSTERIORActive
Quantity: 9 [hp_X] in 1 mL
Code: E8S87O660T
Classification: ACTIB
THYROIDActive
Quantity: 9 [hp_X] in 1 mL
Code: 6RV024OAUQ
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 12 [hp_X] in 1 mL
Code: S7V92P67HO
Classification: ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDEActive
Quantity: 12 [hp_X] in 1 mL
Code: 2E32821G6I
Classification: ACTIB
CONIUM MACULATUM FLOWERING TOPActive
Quantity: 12 [hp_X] in 1 mL
Code: Q28R5GF371
Classification: ACTIB
CORTISONE ACETATEActive
Quantity: 12 [hp_X] in 1 mL
Code: 883WKN7W8X
Classification: ACTIB
CROTALUS HORRIDUS HORRIDUS VENOMActive
Quantity: 12 [hp_X] in 1 mL
Code: YHA2XLJ956
Classification: ACTIB
IRONActive
Quantity: 12 [hp_X] in 1 mL
Code: E1UOL152H7
Classification: ACTIB
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 12 [hp_X] in 1 mL
Code: 269XH13919
Classification: ACTIB
PHOSPHORIC ACIDActive
Quantity: 12 [hp_X] in 1 mL
Code: E4GA8884NN
Classification: ACTIB
PHOSPHORUSActive
Quantity: 12 [hp_X] in 1 mL
Code: 27YLU75U4W
Classification: ACTIB
SELENIUMActive
Quantity: 12 [hp_X] in 1 mL
Code: H6241UJ22B
Classification: ACTIB
SEPIA OFFICINALIS JUICEActive
Quantity: 12 [hp_X] in 1 mL
Code: QDL83WN8C2
Classification: ACTIB
ZANTHOXYLUM AMERICANUM BARKActive
Quantity: 30 [hp_C] in 1 mL
Code: A4KL1HMZ7T
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/9/2025

NDC: 43406-0695-1

STRESS / FATIGUE

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

877730004505

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/13/2025

USES: Temporarily relieves symptoms of stress, fatigue, and simple nervous tension.**

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/9/2025

ACTIVE INGREDIENTS (HPUS)* - equal amounts of: Adrenalinum 9X, Pituitary Gland 9X, Thyroidinum 9X, Arsenicum Alb 12X, Calc Carb 12X, Conium 12X, Cortisone Aceticum 12X, Crotalus Hor 12X, Ferrum Met 12X, Nux Vomica 12X, Phosphoricum Ac 12X, Phosphorus 12X, Selenium 12X Sepia 12X, Xanthoxylum 30C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/13/2025

**USES:**Temporarily relieves symptoms of stress, fatigue, and simple nervous tension.**

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/13/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/13/2025

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 Poison Control Center right away.
  • Do not use ifTAMPER EVIDENT seal is broken or missing.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/13/2025

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 Poison Control Center right away.
  • Do not use ifTAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/13/2025

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/13/2025

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-592-1600

REFERENCES SECTION

LOINC: 34093-5Updated: 8/13/2025
  • The letters "HPUS" indicate that the components in this product are offically monographed in the Homeopathic Pharmacopeia of the United States.

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

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