Label: SLEEP RELIEF- arsenic trioxide - arabica coffee bean - nitric acid - toxicodendron pubescens leaf - selenium - zinc - tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 47242-0061-1 - Packager: Homeostasis Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
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 November 14, 2012
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ACTIVE INGREDIENT
Active Ingredients Purpose Arsenicum album 30C, HPUS Relieves anxiety and restlessness Coffea cruda 30C, HPUS Relaxes the mind Nitricum acidum 30C, HPUS Relieves frequent waking Rhus toxicodendron 30C, HPUS Relieves restlessness Selenium 30C, HPUS Relieves light sleeping Zincum metallicum 30C, HPUS Relieves restlessness "HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.
Statement of Identity: Nighttime sleep aid.
- PURPOSE
- Uses
- Warnings
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
- DO NOT USE
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SLEEP RELIEF
arsenic trioxide - arabica coffee bean - nitric acid - toxicodendron pubescens leaf - selenium - zinc - tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47242-0061 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 30 [hp_C] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 30 [hp_C] NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID 30 [hp_C] TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 30 [hp_C] SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 30 [hp_C] ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 30 [hp_C] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) Product Characteristics Color WHITE Score no score Shape DIAMOND (Rounded) Size 11mm Flavor Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47242-0061-1 1 in 1 PACKAGE 1 50 in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2009 Labeler - Homeostasis Laboratories, Inc. (010569196)