Fever-Infection

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:31:34

Label at a glance#

ProductFever-Infection
Active ingredientMATRICARIA CHAMOMILLA, GELSEMIUM SEMPERVIRENS ROOT, GOLDENSEAL, ACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, CAMPHOR (NATURAL), ARTEMISIA CINA PRE-FLOWERING TOP, CINCHONA OFFICINALIS BARK, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERROSOFERRIC PHOSPHATE, STRYCHNOS IGNATII SEED, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, SALIX NIGRA BARK, VERATRUM VIRIDE ROOT, INFLUENZA B VIRUS, INFLUENZA A VIRUS, CALCIUM SULFIDE, ECHINACEA, UNSPECIFIED
Label structure10 sections

Indications and uses

Formuated for associated symptoms such as chills, aches, sweating, fatigue, nausea and loss of appetite.

Label contents#

Full prescribing information#

INDICATIONS AND USAGE SECTION

INDICATIONS & USAGE SECTION

Formuated for associated symptoms such as chills, aches, sweating, fatigue, nausea and loss of appetite.

DOSAGE & ADMINISTRATION SECTION

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) as needed or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

Warning: If symptoms become severe or fever persists for more than 48 hous, consult a licensed health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Echinacea 6x, Hydrastis canadensis 6x, Aconitum napellus 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Camphora 15x, Cina 15x, Cinchona officinalis 15x, Eupatorium perfoliatum 15x, Ferrum phosphoricum 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Ignatia amara 15x, Natrum muriaticum 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Veratrum viride 15x, Influenzinum 30x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as chills, aches, sweating, fatigue, nausea and loss of appetite.

INACTIVE INGREDIENT SECTION

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

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.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1527-1Fever-Infection30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1527FEVER-INFECTION (CHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUM) LIQUID [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20250129_9d762268-8c30-8a86-e053-2a95a90a419c.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-152755714-1527-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

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
Fever-InfectionCHAMOMILLA, ECHINACEA HYDRASTIS CANADENSIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA OFFICINALIS, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, IGNATIA AMARA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SALIX NIGRA, VERATRUM VIRIDE, INFLUENZINUMNewton Laboratories, Inc.9d762268-8c30-8a86-e053-2a95a90a419c2025-01-27WarningsExact identifier
ndc (package): 55714-1527-1
ndc (product): 55714-1527
ndc11 (package): 55714152701
spl id: 2cb87710-8fb2-747b-e063-6294a90a9fa6
spl set id: 9d762268-8c30-8a86-e053-2a95a90a419c

Reported adverse events (FAERS/openFDA)#

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