SLEEPY JR- chamomilla, cina, cinchona, coffea cruda, nux vom tablet 
Silver Star Brands

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.

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NativeRemedies® Sleepy Jr.™

HPUS Active Ingredients

HPUS Active Ingredients: Equal volumes of each ingredient: Charmomilla 6C, Cina 30C, Cinchona 30C, Coffea cruda 6C, Nux vom 30C.

The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses*

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

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

Directions: Use every night 5 minutes before bedtime until a regular sleep pattern is established. Repeat during the night every 15 minutes for up to 5 doses if necessary. Children 18 months to 3 years: 1 tablet. Children over 3 years: 2 tablets dissolved in mouth. Alternatively, crush and mix in warm water or soft food.

Contains no artificial flavors or colorants. No gluten added.

Tamper resistant for your protection. Use only if safety seals intact.

Inactive Ingredients

Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose.

Keep this and all medication out of reach of children.

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

Relieves occasional sleeplessness & restlessness in toddler and children.

Sleepy Jr

SLEEPY JR 
chamomilla, cina, cinchona, coffea cruda, nux vom tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-316
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (MATRICARIA CHAMOMILLA FLOWERING TOP OIL - UNII:SA8AR2W4ER) MATRICARIA CHAMOMILLA FLOWERING TOP OIL6 [hp_C]
ARTEMISIA CINA FLOWER (UNII: 28M1820ACT) (ARTEMISIA CINA FLOWER - UNII:28M1820ACT) ARTEMISIA CINA FLOWER30 [hp_C]
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q) COFFEA ARABICA FRUIT6 [hp_C]
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
ACACIA (UNII: 5C5403N26O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Colorwhite (Round Lactose Tablets) Scoreno score
ShapeROUND (Round White Lactose Tablets) Size6mm
FlavorImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68703-316-30180 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/17/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/17/2018
Labeler - Silver Star Brands (006070379)
Registrant - Silver Star Brands (006070379)
Establishment
NameAddressID/FEIBusiness Operations
King Bio617901350manufacture(68703-316)

Revised: 3/2023
Document Id: f61ec2fc-47dc-d715-e053-2a95a90a96f6
Set id: 81a22c7c-69a5-ea2a-e053-2991aa0a1a5c
Version: 2
Effective Time: 20230304
 
Silver Star Brands