FDA.reportPublic FDA data

GUNA SLEEP SUPPORT

Manufacturer
Guna spa
Effective date
2021-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:10

Label at a glance#

ProductGUNA SLEEP SUPPORT
Active ingredientPOTASSIUM BROMIDE, CAFFEINE, AVENA SATIVA FLOWERING TOP, MATRICARIA CHAMOMILLA WHOLE, STRYCHNOS IGNATII SEED, PASSIFLORA INCARNATA FLOWERING TOP, SILVER NITRATE, ZINC VALERATE DIHYDRATE
Label structure10 sections

Indications and uses

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

Label contents#

Full prescribing information#

Uses:

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

Take 15 minutes before meals.

INACTIVE INGREDIENT SECTION

inactive ingredient: Ethyl alcohol 30%.

OTC - QUESTIONS SECTION

Questions?: info@gunainc.com

Tel. (484) 223-3500


DOSAGE & ADMINISTRATION 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

WARNINGS 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

OTC - ACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USSLS-45USSLS-4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix5USSLS5USSLS-4.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-471-18GUNA SLEEP SUPPORT30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS301
17089-471-18GUNA SLEEP SUPPORT1 in 1 BOXSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-471GUNA 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 [GUNA SPA]1Current NDC, Legacy NDC, 2 package rows20210117_b3ffb7f9-fd2b-5f88-e053-2a95a90aa91c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-47117089-471-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM BROMIDEOSD78555ZMACTIB
CAFFEINE3G6A5W338EACTIB
ALCOHOL3K9958V90MIACT
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
SILVER NITRATE95IT3W8JZEACTIB
ZINC VALERATE DIHYDRATEMN0RX54EQAACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA SLEEP SUPPORTAVENA SATIVA FLOWERING TOP - CAFFEINE - MATRICARIA CHAMOMILLA WHOLE - PASSIFLORA INCARNATA FLOWERING TOP -POTASSIUM BROMIDE - ZINC VALERATE DIHYDRATE - SILVER NITRATE - STRYCHNOS INGATII SEED -Guna spab3ffb7f9-fd2b-5f88-e053-2a95a90aa91c2021-01-17WarningsExact identifier
ndc (package): 17089-471-18
ndc (product): 17089-471
ndc11 (package): 17089047118
spl id: b3ffb7f9-fd2c-5f88-e053-2a95a90aa91c
spl set id: b3ffb7f9-fd2b-5f88-e053-2a95a90aa91c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.