Active Ingredients:
Avena Sativa 2X, Humulus Lupulus 2X, Passiflora Incarnata 2X, Valeriana Officinalis 2X, Ignatia Amara 6X, Scutellaria Lateriflora 6X, Zincum Metallicum 12X.
Neuro Calming Formula Spray
FDA Label NDC 83027-0013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nutritional Specialties, Inc. for the product Neuro Calming Formula (NDC 83027-0013). 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 active ingredients:, purpose:, warnings:, keep out of reach of children:, directions:, indications:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
For temporary relief of the effects of anxiety and stress-related conditions; sleep enhancer.†
†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:
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:
For temporary relief of the effects of anxiety and stress-related conditions; sleep enhancer.†
†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 83027-0013-1
NEURO CALMING
FORMULA
2 FL. OZ (60 ml)
* Please review the disclaimer below.
