FDA.reportPublic FDA data

Cold - Sinus

Manufacturer
Newton Laboratories, Inc.
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:17:10

Label at a glance#

ProductCold - Sinus
Active ingredientINFLUENZA A VIRUS, AMERICAN GINSENG, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, EUPHRASIA STRICTA, GAULTHERIA PROCUMBENS TOP, GELSEMIUM SEMPERVIRENS ROOT, CALCIUM SULFIDE, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, POTASSIUM DICHROMATE, MERCURY, PHOSPHORUS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SCHOENOCAULON OFFICINALE SEED, SAGE, LOBARIA PULMONARIA, VERBASCUM THAPSUS, ECHINACEA, UNSPECIFIED, INFLUENZA B VIRUS, SINUSITISINUM
Label structure10 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newtton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

INACTIVE INGREDIENT SECTION

Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

OTC - ACTIVE INGREDENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hydrastis 6x, Aralia quin. 15x, Arsenicum alb. 15x, Bryonia 15x, Euphrasia 15x, Gaultheria 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Sabadilla 15x, Salvia 15x, Sticta 15x, Verbascum 15x, Sinusitisinum 16x, Influenzinum 30x.

DOSAGE & ADMINISTRATION SECTION

Ages 12 and up, take 6 pellets by mouth (ages 4 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 4 consult a health professional. Under age 2, crush or dissolve pellets in purfied water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2407-1Cold - Sinus28 g in 1 BOTTLE, GLASSPELLET283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2407COLD - SINUS (INFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEA) PELLET [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20220318_7a433e80-087e-289c-e053-2a91aa0a9447.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-240755714-2407-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
INFLUENZA A VIRUSR9HH0NDE2EACTIB
SUCROSEC151H8M554IACT
AMERICAN GINSENG8W75VCV53QACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GAULTHERIA PROCUMBENS TOP830295X963ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
MERCURYFXS1BY2PGLACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
SAGE065C5D077JACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
SINUSITISINUMB575563DM5ACTIB

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
Cold - SinusINFLUENZA A VIRUS, INFLUENZA B VIRUS, ARALIA QUINQUEFOLIA, ARSENICUM ALB., BRYONIA, EUPHRASIA, GAULTHERIA PROCUBENS, GELSEMIUM, HEPAR SULPH. CALC., HISTAMINUM HYDROCHLORICUM, HYDRASTIS, KALI BIC., MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SABADILLA, SALVIA, STICTA, VERBASCUM, ECHINACEANewton Laboratories, Inc.7a433e80-087e-289c-e053-2a91aa0a94472022-03-17WarningsExact identifier
ndc (package): 55714-2407-1
ndc (product): 55714-2407
ndc11 (package): 55714240701
spl id: da707e07-9b58-6423-e053-2995a90a33b3
spl set id: 7a433e80-087e-289c-e053-2a91aa0a9447

Reported adverse events (FAERS/openFDA)#

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