FDA.reportPublic FDA data

Influenza

Manufacturer
Newton Laboratories, Inc.
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:26:05

Label at a glance#

ProductInfluenza
Active ingredientINFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINE DIHYDROCHLORIDE, ACONITUM NAPELLUS, AMERICAN GINSENG, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, POTASSIUM CARBONATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, ECHINACEA, UNSPECIFIED
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, labored breathing, vomiting and cramping.

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Aconitum nap. 15x, Aralia quin. 15x, Arsenicum album 15x, Baptisia 15x, Bryonia 15x, Cinchona 15x, Eupatorium perf. 15x, Gelsemium 15x, Histaminum hydrochloricum 15x, Ipecac. 15x, Kali carb.15x, Nux vom.15x, Phos. 15x, Rhus tox.15x, Influenzinum 35x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, labored breathing, vomiting and cramping.

INACTIVE INGREDIENT SECTION

Inactive 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 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4854-1Influenza30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4854INFLUENZA (INFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20240216_115edfbe-417b-08b3-e063-6394a90ae6ae.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-485455714-4854-1

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
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
INFLUENZA A VIRUSR9HH0NDE2EACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
AMERICAN GINSENG8W75VCV53QACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
IPECAC62I3C8233LACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB

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
InfluenzaINFLUENZA A VIRUS, INFLUENZA B VIRUS, HISTAMINUM HYDROCHLORICUM, ACONITUM NAP., ARALIA QUINQUEFOLIA, ARSENICUM ALB., BAPTISIA, BRYONIA, CINCHONA, EUPATORIUM PERF., GELSEMIUM, IPECAC., KALI CARB., NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, ECHINACEANewton Laboratories, Inc.115edfbe-417b-08b3-e063-6394a90ae6ae2024-02-14WarningsExact identifier
ndc (package): 55714-4854-1
ndc (product): 55714-4854
ndc11 (package): 55714485401
spl id: 115edfcc-417d-dad8-e063-6294a90a77e6
spl set id: 115edfbe-417b-08b3-e063-6394a90ae6ae

Reported adverse events (FAERS/openFDA)#

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