NDC | 17089-294-18 |
Set ID | 62c57cc4-28c9-406f-821d-1d48370968f2 |
Category | HUMAN OTC DRUG LABEL |
Packager | Guna spa |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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ACTIVE INGREDIENT
Avena sativa 6C Nervousness
Chamomilla 6C Restlessness
Helleborus niger 6C Mental stress
Ignatia amara 6C Restlessness
Interleukin 1 beta 4C Immune support
Melatonin 4C Hormonal regulation
Melissa officinalis 6C Anxiety
Pineal gland 6X 12X 30X Hormonal regulation
Pulsatilla 6C Mood support
Serotonin 6C Hormonal support
Valeriana officinalis 6C Restlessness - PURPOSE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- QUESTIONS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GUNA-SLEEP
avena sativa flowering top - canakinumab - chamomile - helleborus niger root - melatonin - melissa officinalis - pulsatilla vulgaris - serotonin - strychnos ignatii seed - sus scrofa pineal gland - valerian - solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17089-294 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 6 [hp_C] in 30 mL CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_C] in 30 mL HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT 6 [hp_C] in 30 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 6 [hp_C] in 30 mL CANAKINUMAB (UNII: 37CQ2C7X93) (CANAKINUMAB - UNII:37CQ2C7X93) CANAKINUMAB 4 [hp_C] in 30 mL MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN 4 [hp_C] in 30 mL MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS 6 [hp_C] in 30 mL SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7) SUS SCROFA PINEAL GLAND 12 [hp_X] in 30 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_C] in 30 mL SEROTONIN (UNII: 333DO1RDJY) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN 6 [hp_C] in 30 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [hp_C] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17089-294-18 1 in 1 BOX 12/21/2018 1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/23/2006 Labeler - Guna spa (430538264) Establishment Name Address ID/FEI Business Operations Guna spa 338587646 manufacture(17089-294)