Active Ingredients:
(in each tablet) Avena Sativa 6X, Chamomilla 4X, Coffea Cruda 4X, Nux Vomica 6X, Passiflora Incarnata 6X.
Sleep Assist Tablet, Orally Disintegrating
FDA Label NDC 43689-0018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Magni Company for the product Sleep Assist (NDC 43689-0018). 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:, uses:, warnings:, keep out of reach of children:, directions:, other information:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Avena Sativa – For sleeplessness, Chamomilla – For irritability, sleeplessness, and restlessness, Coffea Cruda – For sleeplessness when the mind is awake, Nux Vomica- For those who awake early and cannot get back to sleep, Passiflora Incarnata – For restlessness due to exhaustion.
Uses:
Nighttime sleep aid
Warnings:
• If pregnant or breastfeeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Keep Out Of Reach Of Children:
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
• Adults and children 12 years and above, dissolve 1 to 3 tablets under tongue 1/2 to 1 hour before bedtime.
• Children under 12 years, consult a physician.
Other Information:
Store tightly closed in a dry place
• Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing
• The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United
States
• These statements are supported by the traditional homeopathic principles
Questions:
Dist. by:
The Magni Group, Inc.
McKinney, TX 75071 USA
www.magnilife.com
1-800-645-9199
Package Label Display:
MAGNILIFE® HOMEOPATHIC
SLEEP ASSIST NDC 43689-0018-1
For sleeplessness and
difficulty falling asleep
125 Tablets
* Please review the disclaimer below.
