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NDC 17089-0471-18 GUNA SLEEP SUPPORT 2; 6; 2; 2; 4; 30; 4; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA SLEEP SUPPORT 2; 6; 2; 2; 4; 30; 4; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

GUNA SLEEP SUPPORT is a ORAL SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Guna spa. The primary component is AVENA SATIVA FLOWERING TOP; CAFFEINE; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; SILVER NITRATE; STRYCHNOS IGNATII SEED; ZINC VALERATE DIHYDRATE.

Product Information

NDC	17089-0471
Product ID	17089-471_b3ffb7f9-fd2c-5f88-e053-2a95a90aa91c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	GUNA SLEEP SUPPORT
Proprietary Name Suffix	n/a
Non-Proprietary Name	avena sativa flowering top - caffeine - matricaria chamomilla whole - Passiflora incarnata flowering top -potassium bromide - zinc valerate dihydrate - silver nitrate - strychnos ingatii seed -
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	ORAL
Active Ingredient Strength	2; 6; 2; 2; 4; 30; 4; 4
Active Ingredient Units	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	AVENA SATIVA FLOWERING TOP; CAFFEINE; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; SILVER NITRATE; STRYCHNOS IGNATII SEED; ZINC VALERATE DIHYDRATE
Labeler Name	Guna spa
Pharmaceutical Class	Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17089-0471-18 (17089047118)

Pricing Information	N/A
NDC Package Code	17089-471-18
Billing NDC	17089047118
Package	1 BOTTLE, DROPPER in 1 BOX (17089-471-18) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2021-01-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b3ffb7f9-fd2b-5f88-e053-2a95a90aa91c Details

Uses:

Helps to relax and fall asleep,
Helps to stay asleep during the night

SPL UNCLASSIFIED SECTION

Take 15 minutes before meals.

SPL UNCLASSIFIED SECTION

inactive ingredient: Ethyl alcohol 30%.

SPL UNCLASSIFIED SECTION

Questions?: [email protected]

Tel. (484) 223-3500

SPL UNCLASSIFIED SECTION

Adults and children 12 years and older: 20 drops in a little water, 2 times per day

Children between 12 and 6 years of age: 10 drops in a little water, 2 times per day

Children under 6 years: consulta a physician

SPL UNCLASSIFIED SECTION

Keep out of reach of children

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding ask a health care professional before use

SPL UNCLASSIFIED SECTION

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health care professional before use.
Keep out of reach of children. In case of overdose, get professional assistance or contact a Poison Control Center immediately.
Contains ethyl alcohol 30%

active ingredient/purpose

Avena sativa 2X Helps relaxation, helps sleep

Chamomilla 2X Helps relaxation, helps sleep

Caffeinum 6X Helps relaxation

Ignatia amara 4X Relieves nervousness

Kali bromatum 4X Helps sleep

Passiflora incarnata 2X Supports nighttime sleep

Zincum valerianicum 4X Supports nighttime sleep

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/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17089-471
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/17/2021

Labeler - Guna spa (430538264)

Name	Address	ID/FEI	Business Operations
Establishment
Guna spa		338587646	manufacture(17089-471)

Revised: 1/2021

Document Id: b3ffb7f9-fd2c-5f88-e053-2a95a90aa91c

Set id: b3ffb7f9-fd2b-5f88-e053-2a95a90aa91c

Version: 1

Effective Time: 20210117

Search by Drug Name or NDC

NDC 17089-0471-18 GUNA SLEEP SUPPORT 2; 6; 2; 2; 4; 30; 4; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

GUNA SLEEP SUPPORT 2; 6; 2; 2; 4; 30; 4; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

Product Information

Package

Package Images

NDC 17089-0471-18 (17089047118)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b3ffb7f9-fd2b-5f88-e053-2a95a90aa91c Details

Uses:

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

active ingredient/purpose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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