FDA.reportPublic FDA data

Sinusitis

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:58

Label at a glance#

ProductSinusitis
Active ingredientArsenic Triiodide, Bryonia Alba Root, Helianthemum Canadense, Calcium Sulfide, Histamine Dihydrochloride, Goldenseal, Iodine, Potassium Dichromate, Potassium Iodide, Mercuric Iodide, Mercury, Strychnos Nux-vomica Seed, Phosphorus, Pulsatilla Vulgaris, Schoenocaulon Officinale Seed, Lobaria Pulmonaria, Verbascum Thapsus, Echinacea, Unspecified
Label structure10 sections

Label contents#

Full prescribing information#

PRODUCT NAME & INDICATIONS SECTION

INDICATIONS & USAGE SECTION

Sinusitis  Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections.

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Iodium 15x, Kali bic. 15x, Kali iod.15x, Merc. iod. rub. 15x, Merc. viv. 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta 15x, Verbascum 15x , Echinacea 3x, Hydrastis 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS? SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label
Package Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4418-12020-01-31C16284748780-19d75b9d0-884e-f424-e053-dadaa90a57ceSinusitis
55714-4418-22020-01-31C16284748780-19d75b9d0-884e-f424-e053-dadaa90a57ceSinusitis

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Arsenic TriiodideACTIVE INGREDIENT3029988O2T1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
Helianthemum CanadenseACTIVE INGREDIENT46G3W789Q31
Histamine DihydrochlorideACTIVE INGREDIENT3POA0Q644U1
IodineACTIVE INGREDIENT9679TC07X41
Lobaria PulmonariaACTIVE INGREDIENTD1YM0P5Z2T1
Mercuric IodideACTIVE INGREDIENTR03O05RB0P1
MercuryACTIVE INGREDIENTFXS1BY2PGL1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Potassium DichromateACTIVE INGREDIENTT4423S18FM1
Potassium IodideACTIVE INGREDIENT1C4QK22F9J1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Schoenocaulon Officinale SeedACTIVE INGREDIENT6NAF1689IO1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1721
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Calcium SulfideACTIVE MOIETY1MBW07J51Q1
Dichromate IonACTIVE MOIETY9LKY4BFN2V1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
GoldensealACTIVE MOIETYZW3Z11D0JV1
Helianthemum CanadenseACTIVE MOIETY46G3W789Q31
HistamineACTIVE MOIETY820484N8I31
Iodide IonACTIVE MOIETY09G4I6V86Q1
IodineACTIVE MOIETY9679TC07X41
Lobaria PulmonariaACTIVE MOIETYD1YM0P5Z2T1
Mercuric CationACTIVE MOIETYED30FJ8Y421
MercuryACTIVE MOIETYFXS1BY2PGL1
PhosphorusACTIVE MOIETY27YLU75U4W1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Schoenocaulon Officinale SeedACTIVE MOIETY6NAF1689IO1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Verbascum ThapsusACTIVE MOIETYC9TD27U1721
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-441855714-4418-1, 55714-4418-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
Arsenic Triiodide3029988O2TACTIB
Bryonia Alba RootT7J046YI2BACTIB
Helianthemum Canadense46G3W789Q3ACTIB
Calcium Sulfide1MBW07J51QACTIB
Histamine Dihydrochloride3POA0Q644UACTIB
GoldensealZW3Z11D0JVACTIB
Iodine9679TC07X4ACTIB
Potassium DichromateT4423S18FMACTIB
Potassium Iodide1C4QK22F9JACTIB
Mercuric IodideR03O05RB0PACTIB
MercuryFXS1BY2PGLACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Schoenocaulon Officinale Seed6NAF1689IOACTIB
Lobaria PulmonariaD1YM0P5Z2TACTIB
Verbascum ThapsusC9TD27U172ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
GoldensealZW3Z11D0JVACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
75a1924e-9293-110e-905c-4ecef365bb9ea2c59e0b-1a5b-14df-7ffc-9c50468d92c42011-06-01WarningsExact identifier
spl id: 75a1924e-9293-110e-905c-4ecef365bb9e
spl set id: a2c59e0b-1a5b-14df-7ffc-9c50468d92c4

Reported adverse events (FAERS/openFDA)#

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