FDA Label for Simplex

View Indications, Usage & Precautions

Simplex Product Label

The following document was submitted to the FDA by the labeler of this product Nartex Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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










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