SLEEPY JR- chamomilla, cina, chinchona officinalis, coffea cruda, nux vomica spray

Sleepy Jr by

Drug Labeling and Warnings

Sleepy Jr by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, King Bio. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HPUS Active Ingredients:

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

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.

Warnings:

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:

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:

Citric acid, potassium sorbate, purified water.

KEEP OUT OF REACH OF CHILDREN

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.

PREGNANCY OR BREAST FEEDING

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

PURPOSE

Relieves occasional sleeplessness & restlessness in toddlers & children

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SLEEPY JR 
chamomilla, cina, chinchona officinalis, coffea cruda, nux vomica spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-301
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	30 [hp_C]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_C]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_C]  in 59 mL
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q)	COFFEA ARABICA FRUIT	6 [hp_C]  in 59 mL
ARTEMISIA CINA FLOWER (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT)	ARTEMISIA CINA FLOWER	30 [hp_C]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-301-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/24/2017

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio		617901350	api manufacture(68703-301) , manufacture(68703-301)