Active Ingredients
Ignatia amara 3X HPUS*
Passiflora incarnata 3X HPUS*
Valeriana officinalis 3X HPUS*
Kali phosphoricum 6X HPUS*
Simply Harmony Tablet
FDA Label NDC 34666-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nartex Laboratorios Homeopaticos, S.a. De C.v. for the product Simply Harmony (NDC 34666-403). 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, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Ignatia amara 3X HPUS*.................................Headache, mental fatigue and insomnia from emotional disorders
Passiflora incarnata 3X HPUS*........................Sleeplessness from worries and restlessness
Valeriana officinalis 3X HPUS*........................Restless sleep
Kali phosphoricum 6X HPUS*.........................Mental fatigue, difficulty concentrating, headaches, occasional sleeplessness
*The letters "HPUS" indicate that the compoennts in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.
Uses
For the temporary relief of mental fatigue, difficulty concentrating, headaches, and occasional sleeplessness due to everyday stress. For hard-day periods. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.
Otc - Do Not Use
Do not use
- if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product.
Otc - Stop Use
Stop use and ask a doctor if
- conditoin worsens.
- symptoms persist for more than 7 days or clear up and occur again within a few days.
- rash develops.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, consult a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and older: take 1 tablet every 8 hours. Dissolves slowly in mouth.
- children under 12 years, consult a physician.
Other Information
- store in a cool and dry place.
- do not use if container seal is broken.
Inactive Ingredients
Gelatin, Lactosa USP, Magnesium stearate, Potato starch, Purified water, Sodium benzoate, Talc USP
Questions Or Comments?
[email protected] or call 1-877-248-1970 between 9am and 5pm CST. Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.
Package Label.Principal Display Panel
NDC 34666-403-01
SIMPLY Harmony
Mental Fatigue Relief
- Stay Calm
- Stay Sharp
- Stay Focused
- Mood Support
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.
Homeopathic
120 Tablets
* Please review the disclaimer below.
