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 02:05:22

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

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.

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: Gluten-free, non-GMO, beet-derived sucrose pellets.

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.

PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4419-1	2020-01-31	C162847	48780-1	9d75b9d1-24a2-f424-e053-dadaa90a57ce	Sinusitis
55714-4419-2	2020-01-31	C162847	48780-1	9d75b9d1-24a2-f424-e053-dadaa90a57ce	Sinusitis

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4419-1	Sinusitis	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4419-2	Sinusitis	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4419	SINUSITIS (ARSENICUM IODATUM, BRYONIA, CISTUS CANADENSIS, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, IODIUM, KALI BIC., KALI IOD., MERC. IOD. RUB., MERC. VIV., NUX VOM., PHOSPHORUS, PULSATILLA, SABADILLA, STICTA, VERBASCUM, ECHINACEA) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20140109_da51a41f-8744-ea38-69b7-51282c6d454b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Arsenic Triiodide	ACTIVE INGREDIENT	3029988O2T	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Calcium Sulfide	ACTIVE INGREDIENT	1MBW07J51Q	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Goldenseal	ACTIVE INGREDIENT	ZW3Z11D0JV	1
Helianthemum Canadense	ACTIVE INGREDIENT	46G3W789Q3	1
Histamine Dihydrochloride	ACTIVE INGREDIENT	3POA0Q644U	1
Iodine	ACTIVE INGREDIENT	9679TC07X4	1
Lobaria Pulmonaria	ACTIVE INGREDIENT	D1YM0P5Z2T	1
Mercuric Iodide	ACTIVE INGREDIENT	R03O05RB0P	1
Mercury	ACTIVE INGREDIENT	FXS1BY2PGL	1
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	1
Potassium Dichromate	ACTIVE INGREDIENT	T4423S18FM	1
Potassium Iodide	ACTIVE INGREDIENT	1C4QK22F9J	1
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	1
Schoenocaulon Officinale Seed	ACTIVE INGREDIENT	6NAF1689IO	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Verbascum Thapsus	ACTIVE INGREDIENT	C9TD27U172	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Calcium Sulfide	ACTIVE MOIETY	1MBW07J51Q	1
Dichromate Ion	ACTIVE MOIETY	9LKY4BFN2V	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Goldenseal	ACTIVE MOIETY	ZW3Z11D0JV	1
Helianthemum Canadense	ACTIVE MOIETY	46G3W789Q3	1
Histamine	ACTIVE MOIETY	820484N8I3	1
Iodide Ion	ACTIVE MOIETY	09G4I6V86Q	1
Iodine	ACTIVE MOIETY	9679TC07X4	1
Lobaria Pulmonaria	ACTIVE MOIETY	D1YM0P5Z2T	1
Mercuric Iodide	ACTIVE MOIETY	R03O05RB0P	1
Mercury	ACTIVE MOIETY	FXS1BY2PGL	1
Phosphorus	ACTIVE MOIETY	27YLU75U4W	1
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	1
Schoenocaulon Officinale Seed	ACTIVE MOIETY	6NAF1689IO	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Verbascum Thapsus	ACTIVE MOIETY	C9TD27U172	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

Sinusitis
Arsenicum iodatum, Bryonia, Cistus canadensis, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Iodium, Kali bic., Kali iod., Merc. iod. rub., Merc. viv., Nux vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea
Arsenic Triiodide
Arsenic Cation (3+)
Bryonia Alba Root
Helianthemum Canadense
Calcium Sulfide
Histamine Dihydrochloride
Histamine
Goldenseal
Iodine
Potassium Dichromate
Dichromate Ion
Potassium Iodide
Iodide Ion
Mercuric Iodide
Mercury
Strychnos Nux-vomica Seed
Phosphorus
Pulsatilla Vulgaris
Schoenocaulon Officinale Seed
Lobaria Pulmonaria
Verbascum Thapsus
Echinacea, Unspecified
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4419	55714-4419-1, 55714-4419-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Arsenic Triiodide	3029988O2T	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Helianthemum Canadense	46G3W789Q3	ACTIB
Calcium Sulfide	1MBW07J51Q	ACTIB
Histamine Dihydrochloride	3POA0Q644U	ACTIB
Goldenseal	ZW3Z11D0JV	ACTIB
Iodine	9679TC07X4	ACTIB
Potassium Dichromate	T4423S18FM	ACTIB
Potassium Iodide	1C4QK22F9J	ACTIM
Mercuric Iodide	R03O05RB0P	ACTIB
Mercury	FXS1BY2PGL	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Phosphorus	27YLU75U4W	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Schoenocaulon Officinale Seed	6NAF1689IO	ACTIB
Lobaria Pulmonaria	D1YM0P5Z2T	ACTIB
Verbascum Thapsus	C9TD27U172	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Sucrose	C151H8M554	IACT

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
81dde272-406f-e6a1-a936-d3804b4b7de5			da51a41f-8744-ea38-69b7-51282c6d454b	2011-06-01	Warnings	Exact identifier spl id: 81dde272-406f-e6a1-a936-d3804b4b7de5 spl set id: da51a41f-8744-ea38-69b7-51282c6d454b

Reported adverse events (FAERS/openFDA)#

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