Active Ingredient:
(in each tablet) Chamomilla 4X 0.02%, Ignatia Amara 6X 0.02%, Lycopodium Clavatum 6X 0.02%, Magnesium Muriatica 6X 0.02%, Passiflora Incarnata 4X 0.02%.
Peace And Quiet Tablet, Chewable
FDA Label NDC 70163-0017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naturalcare for the product Peace And Quiet (NDC 70163-0017). 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 ingredient:, purpose, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Chamomilla – fussiness, oversensitivity, crankiness, Ignatia Amara – oversensitivity, crankiness, Lycopodium Clavatum - irritability, Magnesium Muriatica – restlessness, sleeplessness, Passiflora Incarnata – occasional sleeplessness, restlessness*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Uses:
May help temporarily relieve ■ fussiness ■ oversensitivity ■ sleeplessness*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings:
Stop use and ask a doctor if
■ symptoms worsen or continue for more than 14 days
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is missing or open.
■ Store tightly closed at room temperature (65-80°F)
Keep Out Of Reach Of Children:
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
■ children 4 years and over take 3 chewable tablets in mouth every 30 minutes for 4 doses, then reduce to once every 4 hours.
Inactive Ingredients:
croscarmellose sodium, dextrose, lactose, magnesium stearate, microcrystalline cellulose, natural strawberry flavor
Questions:
Dist. By NaturalCare
201 Apple Blvd.
Woodbine, IA 51579
www.NaturalCareWorks.com
1-888-280-5672
Package Label Display:
NaturalCare
childrens
Peace & Quiet
For Restful Calm
Homeopathic
125 Mini Tablets
* Please review the disclaimer below.
