FDA.reportPublic FDA data

Sinus Response

Manufacturer
Beaumont Bio Med | King Bio Inc.
Effective date
2016-09-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:09

Label at a glance#

ProductSinus Response
Active ingredientAPIS MELLIFERA, BAPTISIA TINCTORIA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, CALCIUM SULFIDE, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, STRYCHNOS IGNATII SEED, POTASSIUM DICHROMATE, SKIM MILK, LEMNA MINOR, MERCURY, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SCHOENOCAULON OFFICINALE SEED, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

HPUS active ingredients: Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lac defloratum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis. Equal volumes of each ingredient in 10X, 30X, 100X potencies.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Alcohol (20% v/v), Glycerin (8% v/v), in a pure water base.

INDICATIONS & USAGE SECTION

Indications:​ For temporary relief of: nasal congestion, sinus pressure, sinus headaches associated with the common cold and flu.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Hold close to mouth and spray 1 dose (3 complete pump sprays) directly in mouth 4-6 times daily until symptoms improve.
  • Before initial dose, depress pump 4-5 times or until primed.
  • Consult a physician for use in children under 12 years of age.

Use according to label indications and/or standard homeopathic indications

WARNINGS SECTION

Warnings: If symptoms persist or get worse, consult a physician. If you are pregnant or nursing seek the advice of a physician before using this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep this and all medications out of the reach of children.

OTHER SAFETY INFORMATION

Other Information: Do not use if bottle seal is broken or tampered with.

OTC - PURPOSE SECTION

For temporary relief of:

  • nasal congestion
  • sinus pressure
  • sinus headaches associated with the common cold and flu

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58066-7013-72020-01-31C16284748780-19d75b9d1-276c-f424-e053-dadaa90a57ceSinus Response

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58066-7013-7Sinus Response59.2 mL in 1 BOTTLE, SPRAYLIQUID59.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58066-7013SINUS RESPONSE (APIS MELLIFICA, BAPTISIA TINCTORIA, COLOCYNTHIS, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, KALI BICHROMICUM, LAC DEFLORATUM, LEMNA MINOR, MERCURIUS VIVUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, THUJA OCCIDENTALIS) LIQUID [BEAUMONT BIO MED]1Legacy NDC, 1 package rows20160912_2425a212-cc18-4969-be62-588c6343571d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58066-701358066-7013-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
GOLDENSEALZW3Z11D0JVACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
SKIM MILK6A001Y4M5AACTIB
LEMNA MINOR621HHM46SVACTIB
MERCURYFXS1BY2PGLACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
36749330-05bb-4ca8-8efe-2c5cc70c80ae2425a212-cc18-4969-be62-588c6343571d2016-09-12WarningsExact identifier
spl id: 36749330-05bb-4ca8-8efe-2c5cc70c80ae
spl set id: 2425a212-cc18-4969-be62-588c6343571d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.