Label: SNORE CONTROL- bromium, chamomilla, cinchona officinalis, cuprum metallicum, helleborus niger, laurocerasus, nux vomica, phosphoricum acidum, rhus toxicodendron, silicea. stramonium, zincum metallicum liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-5120-2 - Packager: King Bio Inc.
- 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 September 2, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INDICATIONS & USAGE
Uses for temporary relief of symptoms related to snoring:
█ slow, labored breathing █ stuffy nose, especially at night
█ heaviness of chest █ dry cough.
† as per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested. - WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- QUESTIONS
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INACTIVE INGREDIENT
Inactive Ingredients:
Bio-Energetically Enhanced™ pure
water, citrus extract* (ascorbic
acid, citric acid, citrus aurantium
amara fruit extract, citrus
aurantium sinensis peel extract,
citrus reticulata fruit extract,
demineralized water, glycerin,
lactic acid), Honeysuckle (Lonicera
japonica), polylysine, Shagbark
Hickory (Carya ovata) Bark
Extract, steviol (Steviol
glycosides). -
PURPOSE
HPUS active Ingredients: Purpose:
Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.
Bromium...................................jerking and starting during sleep
Chamomilla .....................................................tightness of chest
Cinchona officinalis ................................slow, labored breathing
Cuprum metallicum ...........................................spasms of chest
Helleborus niger...........................................irregular respiration
Laurocerasus ...............................spasmodic tickling, dry cough
Nux vomica .................................stuffy nose, especially at night
Phosphoricum acidum......................................difficult breathing
Rhus tox.............................heaviness of chest, bronchial cough
Silicea...................................................coughs when lying down
Stramonium............................................................ deep snoring
Zincum metallicum ....................................................hoarseness
**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SNORE CONTROL
bromium, chamomilla, cinchona officinalis, cuprum metallicum, helleborus niger, laurocerasus, nux vomica, phosphoricum acidum, rhus toxicodendron, silicea. stramonium, zincum metallicum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-5120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE 10 [hp_X] in 59 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 10 [hp_X] in 59 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 10 [hp_X] in 59 mL COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 10 [hp_X] in 59 mL HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT 10 [hp_X] in 59 mL PRUNUS LAUROCERASUS LEAF (UNII: F26P2D4757) (PRUNUS LAUROCERASUS LEAF - UNII:F26P2D4757) PRUNUS LAUROCERASUS LEAF 10 [hp_X] in 59 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 10 [hp_X] in 59 mL PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 10 [hp_X] in 59 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 [hp_X] in 59 mL DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 10 [hp_X] in 59 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARYA OVATA BARK (UNII: X765CF609L) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR) REBAUDIOSIDE A (UNII: B3FUD0528F) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-5120-2 1 in 1 CARTON 02/01/2019 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/01/2019 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-5120) , api manufacture(57955-5120)
