Label: GUNA SLEEP SUPPORT- avena sativa flowering top - caffeine - matricaria chamomilla whole - passiflora incarnata flowering top -potassium bromide - zinc valerate dihydrate - silver nitrate - strychnos ingatii seed - solution/ drops
- NDC Code(s): 17089-471-18
- Packager: Guna spa
- 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 January 17, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Uses:
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- DOSAGE & ADMINISTRATION
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- WARNINGS
- active ingredient/purpose
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GUNA SLEEP SUPPORT
avena sativa flowering top - caffeine - matricaria chamomilla whole - passiflora incarnata flowering top -potassium bromide - zinc valerate dihydrate - silver nitrate - strychnos ingatii seed - solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17089-471 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 4 [hp_X] in 30 mL CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 6 [hp_X] in 30 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 2 [hp_X] in 30 mL MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA WHOLE - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE 2 [hp_X] in 30 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 4 [hp_X] in 30 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X] in 30 mL SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 30 [hp_X] in 30 mL ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE 4 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17089-471-18 1 in 1 BOX 01/17/2021 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 01/17/2021 Labeler - Guna spa (430538264) Establishment Name Address ID/FEI Business Operations Guna spa 338587646 manufacture(17089-471)