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Snore Control

Snore Control

Approved
Approval ID

46456a03-7db4-4c63-9475-32dcd084aab9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 19, 2025

Manufacturers
FDA

King Bio Inc.

DUNS: 617901350

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Bromium, Chamomilla, Cinchona officinalis, Cuprum metallicum, Helleborus niger, Laurocerasus, Nux vomica, Phosphoricum acidum, Rhus tox, Silicea, Stramonium, Zincum metallicum.

PRODUCT DETAILS

NDC Product Code57955-5122
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMay 19, 2025
Generic NameBromium, Chamomilla, Cinchona officinalis, Cuprum metallicum, Helleborus niger, Laurocerasus, Nux vomica, Phosphoricum acidum, Rhus tox, Silicea, Stramonium, Zincum metallicum.

INGREDIENTS (24)

BROMINEActive
Quantity: 10 [hp_X] in 59 mL
Code: SBV4XY874G
Classification: ACTIB
MATRICARIA CHAMOMILLA WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: G0R4UBI2ZZ
Classification: ACTIB
CINCHONA OFFICINALIS BARKActive
Quantity: 10 [hp_X] in 59 mL
Code: S003A158SB
Classification: ACTIB
COPPERActive
Quantity: 10 [hp_X] in 59 mL
Code: 789U1901C5
Classification: ACTIB
HELLEBORUS NIGER ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: 608DGJ6815
Classification: ACTIB
PRUNUS LAUROCERASUS LEAFActive
Quantity: 10 [hp_X] in 59 mL
Code: F26P2D4757
Classification: ACTIB
PHOSPHORIC ACIDActive
Quantity: 10 [hp_X] in 59 mL
Code: E4GA8884NN
Classification: ACTIB
TOXICODENDRON PUBESCENS LEAFActive
Quantity: 10 [hp_X] in 59 mL
Code: 6IO182RP7A
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 10 [hp_X] in 59 mL
Code: ETJ7Z6XBU4
Classification: ACTIB
DATURA STRAMONIUMActive
Quantity: 10 [hp_X] in 59 mL
Code: G6W4F0V8Z3
Classification: ACTIB
ZINCActive
Quantity: 10 [hp_X] in 59 mL
Code: J41CSQ7QDS
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0T
Classification: IACT
ORANGE PEELInactive
Code: TI9T76XD44
Classification: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4Y
Classification: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWR
Classification: IACT
CARYA OVATA BARKInactive
Code: X765CF609L
Classification: IACT
STEVIOLInactive
Code: 4741LYX6RT
Classification: IACT
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 10 [hp_X] in 59 mL
Code: 269XH13919
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/13/2022

image description Snore Control.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/13/2022

Uses

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.

Reference image:Snore Control.jpg

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/13/2022

Directions

Initially, depress pump until
primed.

Spray one dose directly into
mouth.

Adults: 3 sprays 3 times per
day.

Children ages 6-12: 2 sprays 3
times per day.

Consult a physician for use in
children under 6 years of age.

Use additionally as needed, up
to 6 times per day.

Reference image:Snore Control.jpg

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/13/2022

Other information

Tamper resistant for your protection.

Use only if safety seal is intact.

Keep carton for complete drug facts and product information.

Questions? Call 866.298.2740

King Bio, Inc. 3 Westside Drive

Asheville, NC 2806 USA

FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

Reference image:Snore Control.jpg

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/13/2022

Inactive Ingredients

Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

Reference image:Snore Control.jpg

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/13/2022

Active ingredients

Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.

Bromium, Chamomilla, Cinchona officinalis, Cuprum metallicum, Helleborus niger, Laurocerasus, Nux vomica, Phosphoricum acidum, Rhus tox,
Silicea, Stramonium, Zincum metallicum.

HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Reference image:Snore Control.jpg

WARNINGS SECTION

LOINC: 34071-1Updated: 12/13/2022

Warnings

Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.

If pregnant or breast-feeding, ask a healthcare professional
before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Snore Control.jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/13/2022

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Snore Control.jpg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/13/2022

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.

Reference image:Snore Control.jpg

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Snore Control - FDA Drug Approval Details