Label: SLEEPY JR- chamomilla, cina, chinchona officinalis, coffea cruda, nux vomica spray
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Contains inactivated NDC Code(s)
NDC Code(s): 68703-301-02 - Packager: Silver Star Brands
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated April 13, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- HPUS Active Ingredients:
- Uses*:
- Warnings:
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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.
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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:
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SLEEPY JR
chamomilla, cina, chinchona officinalis, coffea cruda, nux vomica sprayProduct 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)
