Otc - Active Ingredient
Ignatia amara 3X HPUS
Passiflora incarnata 3X HPUS
Valeriana officinalis 3X HPUS
Simplex Tablet
FDA Label NDC 34666-008
12 label sections · Submitted to the FDA by Nartex Laboratories · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nartex Laboratories for the product Simplex (NDC 34666-008). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Ignatia Amara 3X HPUS.....................Sleeplessnes, worry
Passiflora incarnata 3X HPUS.............Nervousness, sleeplessness
Valeriana oficinalis 3X HPUS..............Sleeplessness
Indications & Usage
For relief of symptoms of sleeplessness and stress as per homeopathic materia medica. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and poduct has not been clinically tested.
Warnings
Do not use
- if you have an allergy or hypersensitivity to components of the formula
Otc - Stop Use
Stop use and ask a doctor if
- discomfort persists
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
- Adults and children over 12 years: take 2 tablets every 4 hours during the day. Dissolve slowly in the mouth.
- Children under 12: Do not use.
Storage And Handling
- store in a cool and dry place
Inactive Ingredient
Gelatin, Lactose USP, Magnesium Stearate, Potato Starch, Purified water, Sodium Benzoate, Talc USP
Otc - Questions
Package Label.Principal Display Panel
NDC 34666-008-06
Homeopathic Simplex
Ignatia amara, Passiflora incaranata, Valeriana officinalis
Relieves symptoms of Sleeplessness and Stress
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.
Stress Control
Directions
2 tablets every 4 hours**
* Based on homeopathic materia medica
** See directions at the back
6 tablets
* Please review the disclaimer below.
