{"active_ingredient":["Active ingredients Passiflora incarnata 1X HPUS* Valeriana officinalis 1X HPUS*"],"do_not_use":["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."],"dosage_and_administration":["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."],"effective_time":"20211203","id":"d2439b65-3876-c1a6-e053-2a95a90a40aa","inactive_ingredient":["Inactive ingredients Gelatin, Lactosa USP, Magnesium stearate, Potato starch, Purified water, Sodium benzoate, Talc USP"],"indications_and_usage":["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."],"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."],"openfda":{"brand_name":["Simply Dreams"],"generic_name":["PASSIFLORA INCARNATA, VALERIANA OFFICINALIS"],"is_original_packager":[true],"manufacturer_name":["Nartex Laboratorios Homeopaticos, S.A. De C.V."],"package_ndc":["34666-402-01"],"product_ndc":["34666-402"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["d2439b65-3876-c1a6-e053-2a95a90a40aa"],"spl_set_id":["d2439b65-3875-c1a6-e053-2a95a90a40aa"],"substance_name":["PASSIFLORA INCARNATA FLOWERING TOP","VALERIAN"],"unii":["CLF5YFS11O","JWF5YAW3QW"],"upc":["0844827001419"]},"package_label_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 1 2"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, consult a health professional before use."],"purpose":["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."],"questions":["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."],"set_id":"d2439b65-3875-c1a6-e053-2a95a90a40aa","spl_product_data_elements":["Simply Dreams Passiflora incarnata, Valeriana officinalis PASSIFLORA INCARNATA FLOWERING TOP PASSIFLORA INCARNATA FLOWERING TOP SODIUM BENZOATE GELATIN VALERIAN VALERIAN STARCH, POTATO TALC MAGNESIUM STEARATE WATER LACTOSE, UNSPECIFIED FORM LogoNartex"],"stop_use":["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."],"storage_and_handling":["Other information store in a cool and dry place. do not use if container seal is broken."],"version":"1","warnings":["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."]}