FDA.reportPublic FDA data

Fever-Infection

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:12:11

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 pellets by mouth (ages 12 and up, give 6 pellets) as needed or a directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet 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

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

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.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-1727-12023-01-30C16284748780-1f386c649-dd4b-0266-e053-dadaa90a7c1aFever 1727P

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1727-1Fever-Infection28 g in 1 BOTTLE, GLASSPELLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1727FEVER-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) PELLET [NEWTON LABORATORIES, INC.]1Legacy NDC, 1 package rows20200204_9d774414-f8f7-51af-e053-2995a90a47de.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
55714-172755714-1727-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
GOLDENSEALZW3Z11D0JVACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
ARTEMISIA CINA PRE-FLOWERING TOP28M1820ACTACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SUCROSEC151H8M554IACT
SALIX NIGRA BARKQU52J3A5B3ACTIB
VERATRUM VIRIDE ROOT197B3Q7T5QACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
INFLUENZA A VIRUSR9HH0NDE2EACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
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 · 11 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-e053-2a95a90a419c2025-01-27WarningsName fallback
brand name: Fever-Infection
ChamomillaMATRICARIA CHAMOMILLABoiron851950ec-62cf-30ad-e053-2991aa0a19bd2024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron8519dcba-d2e1-ffb8-e053-2a91aa0a7ada2024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron851a3706-cc8c-b3f8-e053-2a91aa0ac0f52024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron8519c019-9944-7c11-e053-2a91aa0afddd2024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron85192110-5d56-59f7-e053-2a91aa0a48612024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron8519369a-b96f-4bf7-e053-2991aa0aee3a2024-07-23Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron851978dd-d0dd-208c-e053-2a91aa0a30c52024-07-22Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron8519e65a-803a-2986-e053-2a91aa0aadfd2024-07-22Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron851950ec-62b1-30ad-e053-2991aa0a19bd2024-07-22Name fallback
generic name: MATRICARIA CHAMOMILLA
ChamomillaMATRICARIA CHAMOMILLABoiron851a1844-b599-62c5-e053-2a91aa0a81742024-07-22Name fallback
generic name: MATRICARIA CHAMOMILLA

Reported adverse events (FAERS/openFDA)#

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