FDA.reportPublic FDA data

Clear Sinuses

Manufacturer
Ella Care, LLC
Effective date
2016-09-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:08:08

Label at a glance#

ProductClear Sinuses
Active ingredientAPIS MELLIFERA, BAPTISIA TINCTORIA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, CALCIUM SULFIDE, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, STRYCHNOS IGNATII SEED, POTASSIUM DICHROMATE, LEMNA MINOR, MERCURY, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SCHOENOCAULON OFFICINALE SEED, THUJA OCCIDENTALIS LEAFY TWIG
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions: Initially depress pump until primed. Spray one dose directly in mouth. Use additionally as needed up to 6 times per day.

Children 2 MO-2YR: 1 spray 3 times per day

Children 2-12 YR: 2 spray 3 times per day

WARNINGS SECTION

Warnings: If symptoms persist more than seven days or worsen, seek advice of a physician. If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Indications: For temporary relief of symptoms associated with sinusitis, hay fever or upper respiratory allergies such as runny nose, sinus pain and pressure, sneezing, sinus headache, nasal congestion, mucus drainage, sore or dry throat, and / or itchy, burning, or red eyes.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis. ​Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Citric acid, potassium sorbate, and purified water.

INDICATIONS & USAGE SECTION

Indications: For temporary relief of symptoms associated with sinusitis hay fever or upper respiratory allergies such as:

  • runny nose
  • sinus pain and pressure
  • sneezing
  • sinus headache
  • nasal congestion
  • mucus drainage
  • sore or dry throat
  • itchy, burning, or red eyes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70851-0001-22020-01-31C16284748780-19d75b9d0-6dcc-f424-e053-dadaa90a57ceClear Sinuses

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70851-0001-2Clear Sinuses59 mL in 1 BOTTLE, SPRAYLIQUID593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70851-0001CLEAR SINUSES (APIS MELLIFICA, BAPTISIA TINCTORIA, COLOCYNTHIS, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, KALI BICHROMICUM, LEMNA MINOR, MERCURIUS VIVUS, PULSATILLA, RHUS TOXICODENRON, SABADILLA, THUJA OCCIDENTALIS) LIQUID [ELLA CARE, LLC]3Legacy NDC, 1 package rows20160902_7ca4f8a7-fdf6-4ba6-bab5-190713d7f0ba.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70851-000170851-0001-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
LEMNA MINOR621HHM46SVACTIB
MERCURYFXS1BY2PGLACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
APIS MELLIFERAAPIS MELLIFERASEVENE USA44713715-fea5-4c14-87c2-1373968474a52025-05-22WarningsName fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron84607a01-93fb-29a3-e053-2a91aa0ac5a62025-03-04WarningsName fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron84ecbfe7-bceb-4b87-e053-2a91aa0ad12c2025-03-04WarningsName fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron84603461-009c-043c-e053-2991aa0a3f1e2025-03-04WarningsName fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron846048d5-24dd-e76b-e053-2a91aa0a27d22025-03-04WarningsName fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron979db987-3a74-4ab6-9b3a-d8b32fedb7e52025-03-04WarningsName fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron84606086-b4e0-4430-e053-2a91aa0ab6772025-03-04WarningsName fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron84ec87f5-b424-ca51-e053-2a91aa0a555f2024-12-19Name fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron8460667b-79ac-cd53-e053-2991aa0adb3e2024-12-19Name fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron84ec87f5-b41a-ca51-e053-2a91aa0a555f2024-12-19Name fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron84ec606d-1862-cd33-e053-2991aa0a5f502024-12-19Name fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron8460dca1-0966-381a-e053-2991aa0a5a8a2024-12-19WarningsName fallback
generic name: APIS MELLIFERA
Apis mellificaAPIS MELLIFERABoiron84ecd65d-2e4d-7882-e053-2991aa0ac2ca2024-12-19Name fallback
generic name: APIS MELLIFERA

Reported adverse events (FAERS/openFDA)#

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