SIMPLEX- passiflora incarnata, ignatia amara, valeriana officinalis tablet

Simplex by

Drug Labeling and Warnings

Simplex by is a Homeopathic medication manufactured, distributed, or labeled by Nartex Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Passiflora incarnata

Ignatia amara

Valeriana officinalis

INDICATIONS & USAGE

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

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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding:

• ask a health professional before use.
  

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

QUESTIONS

Questions or Comments?

P.O. Box 1261, Downey CA 90240

52+(871) 721.0855

www.Nartexlabs.com

PRINCIPAL DISPLAY PANEL

Relieves symptoms of Sleeplessness and Stress

INGREDIENTS AND APPEARANCE

SIMPLEX 
passiflora incarnata, ignatia amara, valeriana officinalis tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z)	PASSIFLORA INCARNATA FLOWER	3 [hp_X]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	3 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, POTATO (UNII: 8I089SAH3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-008-60	60 in 1 BOX; Type 0: Not a Combination Product	12/23/2010
2	NDC: 34666-008-06	6 in 1 BOX; Type 0: Not a Combination Product	12/23/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/23/2010

Labeler - Nartex Laboratories (589914576)

Registrant - Nartex Laboratories (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
Nartex Laboratories		589914576	manufacture(34666-008)