Label: SPRAYOLOGY SLEEPEASE- aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, kali phosphoricum, passiflora incarnata, valeriana officinalis, zincum metallicum liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 61096-1001-2 - Packager: Eight and Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated July 28, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
WARNINGS
Warnings: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SPRAYOLOGY SLEEPEASE
aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, kali phosphoricum, passiflora incarnata, valeriana officinalis, zincum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61096-1001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AQUILEGIA VULGARIS (UNII: 8POZ61U1G2) (AQUILEGIA VULGARIS - UNII:8POZ61U1G2) AQUILEGIA VULGARIS 2 [hp_X] in 41 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 2 [hp_X] in 41 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 2 [hp_X] in 41 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 200 [hp_C] in 41 mL CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFOLUM ROOT 3 [hp_X] in 41 mL HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 3 [hp_X] in 41 mL POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 12 [hp_X] in 41 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X] in 41 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 2 [hp_X] in 41 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 12 [hp_X] in 41 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61096-1001-2 1 in 1 CARTON 07/28/2016 1 41 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/28/2016 Labeler - Eight and Company (927364120) Registrant - Eight and Company (927364120)
