SIMPLY DREAMS- passiflora incarnata, valeriana officinalis tablet 
Nartex Laboratorios Homeopaticos, S.A. De C.V.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Simply Dreams

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

Other information

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.

NDC 34666-402-01

SIMPLY Dreams

Nighttime Sleep Aid

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Homeopathic

80 Tablets

1

2

SIMPLY DREAMS 
passiflora incarnata, valeriana officinalis tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-402
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP1 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScorescore with uneven pieces
ShapeROUNDSize9mm
FlavorImprint Code LogoNartex
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34666-402-011 in 1 CARTON12/03/2021
180 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/03/2021
Labeler - Nartex Laboratorios Homeopaticos, S.A. De C.V. (589914576)
Establishment
NameAddressID/FEIBusiness Operations
Nartex Laboratorios Homeopaticos, S.A. De C.V.589914576manufacture(34666-402)

Revised: 12/2021
Document Id: d2439b65-3876-c1a6-e053-2a95a90a40aa
Set id: d2439b65-3875-c1a6-e053-2a95a90a40aa
Version: 1
Effective Time: 20211203
 
Nartex Laboratorios Homeopaticos, S.A. De C.V.