FDA.reportPublic FDA data

Sinu-S

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:56

Label at a glance#

ProductSinu-S
Active ingredientECHINACEA, UNSPECIFIED, SCHOENOCAULON OFFICINALE SEED, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, HELIANTHEMUM CANADENSE, CALCIUM SULFIDE, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, POTASSIUM IODIDE, MERCURIC IODIDE, MERCURY, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, VERBASCUM THAPSUS, SINUSITISINUM, LOBARIA PULMONARIA, GOLDENSEAL
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Hydrastis canadensis 15x, Iodium 15x, Kali bichromicum 15x, Kali iodatum 15x, Mercurius iodatus ruber 15x, Mercurius vivus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta pulmonaria 15x, Verbascum thapsus 15x, Sinusitisinum 16x.

OTC - PURPOSE SECTION

Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.

INACTIVE INGREDIENT SECTION

I nactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4778-1Sinu-S30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4778SINU-S (ECHINACEA, HYDRASTIS CANADENSIS, ARSENICUM IODATUM, BRYONIA, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, KALI IODATUM, MERCURIUS IODATUS RUBER, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS PULSATILLA, SABADILLA, STICTA , VERBASCUM THAPSUS, SINUSITISINUM) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201208_9a667ff9-9438-2cef-e053-2995a90ac0a2.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-477855714-4778-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
HELIANTHEMUM CANADENSE46G3W789Q3ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
IODINE9679TC07X4ACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
POTASSIUM IODIDE1C4QK22F9JACTIB
MERCURIC IODIDER03O05RB0PACTIB
MERCURYFXS1BY2PGLACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
VERBASCUM THAPSUSC9TD27U172ACTIB
SINUSITISINUMB575563DM5ACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
GOLDENSEALZW3Z11D0JVACTIB

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
Sinu-SECHINACEA, HYDRASTIS CANADENSIS, ARSENICUM IODATUM, BRYONIA, CISTUS CANADENSIS, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, KALI IODATUM, MERCURIUS IODATUS RUBER, MERCURIUS VIVUS, NUX VOMICA, PHOSPHORUS PULSATILLA, SABADILLA, STICTA , VERBASCUM THAPSUS, SINUSITISINUMNewton Laboratories, Inc.9a667ff9-9438-2cef-e053-2995a90ac0a22020-12-07WarningsExact identifier
ndc (package): 55714-4778-1
ndc (product): 55714-4778
ndc11 (package): 55714477801
spl id: b5e44078-0ba2-c029-e053-2995a90aefcf
spl set id: 9a667ff9-9438-2cef-e053-2995a90ac0a2

Reported adverse events (FAERS/openFDA)#

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