Simplex Tablet
FDA Label NDC 34666-008

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 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, indications & usage, otc - purpose, 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 - Active Ingredient

Passiflora incarnata

Ignatia amara

Valeriana officinalis




Indications & Usage

For relief of symptoms of sleeplessness and stress as per homeopathic materia medica

Otc - Purpose

Passiflora incarnata.............Nervousness, sleeplessness

Ignatia Amara.....................Sleeplessnes, worry

Valeriana oficinalis..............Sleeplessness

Warnings

Do not:

  • use if you have an allergy or hypersensitivity to components of the formula
  • give to children under 12 years of age

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:

  • ask 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.

Dosage & Administration

Directions:

  • adults take 2 orally every 4 hours during the day.  Dissolves slowly in mouth.

Storage And Handling

store in a cool and dry place

Inactive Ingredient

Gelatin, Lactose, Magnesium Stearate, Potato Starch, Sodium Benzoate, Talc

Otc - Questions

Questions or Comments?

P.O. Box 1261, Downey CA 90240

52+(871) 721.0855

www.Nartexlabs.com

Package Label.Principal Display Panel

Relieves symptoms of Sleeplessness and Stress

Simplex Front Carton (Simplexfrontcarton)

Simplex Front Carton (Simplexfrontcarton)


Simplex Back Carton (Simplexbackcarton)

Simplex Back Carton (Simplexbackcarton)








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