SIMPLY DREAMS- passiflora incarnata, valeriana officinalis tablet

Simply Dreams by

Drug Labeling and Warnings

Simply Dreams by is a Homeopathic medication manufactured, distributed, or labeled by Nartex Laboratorios Homeopaticos, S.A. De C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Passiflora incarnata 1X HPUS*

Valeriana officinalis 1X HPUS*

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.

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.

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.

If pregnant or breast feeding, consult a health professional before use.

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?

informacion@nartexlabs.com 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.

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

INGREDIENTS AND APPEARANCE

SIMPLY DREAMS 
passiflora incarnata, valeriana officinalis tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-402
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	1 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
GELATIN (UNII: 2G86QN327L)
STARCH, POTATO (UNII: 8I089SAH3T)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
WATER (UNII: 059QF0KO0R)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	LogoNartex
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-402-01	1 in 1 CARTON	12/03/2021
1		80 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/03/2021

Labeler - Nartex Laboratorios Homeopaticos, S.A. De C.V. (589914576)

Establishment
Name	Address	ID/FEI	Business Operations
Nartex Laboratorios Homeopaticos, S.A. De C.V.		589914576	manufacture(34666-402)