Sleepy Jr

Manufacturer
Silver Star Brands | King Bio
Effective date
2017-04-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:51

Label at a glance#

ProductSleepy Jr
Active ingredientCINCHONA OFFICINALIS BARK, STRYCHNOS NUX-VOMICA SEED, MATRICARIA RECUTITA, COFFEA ARABICA FRUIT, ARTEMISIA CINA FLOWER
Label structure10 sections

Indications and uses

Homeopathic remedy to relieve occasional sleeplessness and restlessness in toddlers and children. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Dosage and administration

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Alternatively, the spray may be dispensed into a little water or juice. Use every night 15 minutes before bedtime until a regular sleep pattern is established. Repeat up to 3 times during the night if necessary. Children 18 months to 3 years: 1 pump spray. Chidlren over 3 years: 2 pump sprays.

Label contents#

Full prescribing information#

HPUS Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Equal volumes of each ingredient: Chamomilla 6C, Cina 30C, Cinchona officinalis 30C, Coffea cruda 6C, Nux vomica 30C.

Uses*:

INDICATIONS & USAGE SECTION

Homeopathic remedy to relieve occasional sleeplessness and restlessness in toddlers and children.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings:

WARNINGS SECTION

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Alternatively, the spray may be dispensed into a little water or juice. Use every night 15 minutes before bedtime until a regular sleep pattern is established. Repeat up to 3 times during the night if necessary. Children 18 months to 3 years: 1 pump spray. Chidlren over 3 years: 2 pump sprays.

OTHER SAFETY INFORMATION

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. Fore more information, visit us at www.nativeremedies.com. Contains no artificial flavors or colorants. No gluten added.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, potassium sorbate, purified water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - PURPOSE SECTION

Relieves occasional sleeplessness & restlessness in toddlers & children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleepy JrSleepy Jr

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-301-022020-01-31C16284748780-19d75b9d0-b779-f424-e053-dadaa90a57ceNativeRemedies® Sleepy Jr.™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-301-02Sleepy Jr59 mL in 1 BOTTLE, SPRAYSPRAY591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-301SLEEPY JR (CHAMOMILLA, CINA, CHINCHONA OFFICINALIS, COFFEA CRUDA, NUX VOMICA) SPRAY [SILVER STAR BRANDS]1Legacy NDC, 1 package rows20170621_4d11cc46-3939-1561-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-30168703-301-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
4d11cc46-393a-1561-e054-00144ff8d46c4d11cc46-3939-1561-e054-00144ff8d46c2017-04-13WarningsExact identifier
spl id: 4d11cc46-393a-1561-e054-00144ff8d46c
spl set id: 4d11cc46-3939-1561-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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