Active Ingredients
Passiflora incarnata 1X HPUS*
Valeriana officinalis 1X HPUS*
Simply Dreams Tablet
FDA Label NDC 34666-402
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 Dreams (NDC 34666-402). 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, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Passiflora incarnata 1X HPUS*...................Sleeplessness from worries and restlessness
Valeriana officinalis 1X HPUS*....................Restless sleep
*The letters "HPUS" indicate that the components 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
Reduces time to fall asleep if you have difficulty falling asleep. For relief of occasional sleeplessness or intermittent awakening. Helps to reduce difficulty falling asleep. 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.
Warnings
If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
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.
- for children under 12 years of age.
Otc - Stop Use
Stop use and ask a doctor if
- condition 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 2 tablets every 24 hours. Dissolves slowly in mouth.
- children under 12 years, do not use.
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 34666-402-01
SIMPLY Dreams
Nighttime Sleep Aid
- Helps falling asleep naturally
- No day-time grogginess
- Calms restless sleep
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.
Homeopathic
80 Tablets
* Please review the disclaimer below.
