The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc. for the product Stress / Fatigue (NDC 43406-0695). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Uses: Temporarily relieves symptoms of stress, fatigue, and simple nervous tension.**
Uses: Temporarily relieves symptoms of stress, fatigue, and simple nervous tension.**
Directions: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.
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:
*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 Ingredients: Ethyl Alcohol USP , Purified Water.
Questions & Comments?
Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600
*The letters "HPUS" indicate the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
NDC: 43406-0695-1
STRESS / FATIGUE
HOMEOPATHIC
1 fl oz (30 mL) 20% Alcohol
* Please review the disclaimer below.
