FDA.reportPublic FDA data

Fever - Infection

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:31:48

Label at a glance#

ProductFever - Infection
Active ingredientBACILLUS ANTHRACIS IMMUNOSERUM RABBIT, INFLUENZA A VIRUS, RANCID BEEF, ACONITUM NAPELLUS, ANTIMONY POTASSIUM TARTRATE, ARNICA MONTANA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, BRYONIA ALBA ROOT, LYTTA VESICATORIA, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, EUPATORIUM PERFOLIATUM FLOWERING TOP, IRON, GELSEMIUM SEMPERVIRENS ROOT, CALCIUM SULFIDE, IODINE, LACHESIS MUTA VENOM, MERCURY, PHOSPHORUS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SALIX NIGRA BARK, VERBASCUM THAPSUS, APIS MELLIFERA, ECHINACEA, UNSPECIFIED, GOLDENSEAL, INFLUENZA B VIRUS
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

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. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: If symptoms become severe or fever persists for more than 48 hours, consult a licensed health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 6x, Echinacea 6x, Hydrastis 6x, Aconitum nap. 15x, Antimon. tart. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chamomilla 15x, Cinchona 15x, Eupatorium perf. 15x, Ferrum metallicum 15x, Gelsemium 15x, Hepar sulph.calc. 15x, Iodium 15x, Lachesis 15x, Merc. viv. 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Salix nigra 15x, Verbascum 15x, Anthracinum 30x, Influenzinum 30x, Pyrogenium 30x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

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.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

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

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
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
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
55714-2440-0Fever - Infection0.5 mL in 1 BOTTLE, GLASSLIQUID0.54
55714-2440-1Fever - Infection30 mL in 1 BOTTLE, GLASSLIQUID304
55714-2440-2Fever - Infection50 mL in 1 BOTTLE, GLASSLIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2440FEVER - INFECTION (ANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTIS) LIQUID [NEWTON LABORATORIES, INC.]4Current NDC, Legacy NDC, 3 package rows20250209_8f023019-5c58-e0de-e053-2a95a90accfd.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-244055714-2440-1, 55714-2440-2, 55714-2440-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB
INFLUENZA A VIRUSR9HH0NDE2EACTIB
RANCID BEEF29SUH5R3HUACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA5K1UO2888YACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
IRONE1UOL152H7ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
IODINE9679TC07X4ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MERCURYFXS1BY2PGLACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SALIX NIGRA BARKQU52J3A5B3ACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
GOLDENSEALZW3Z11D0JVACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB

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 - InfectionANTHRACINUM, INFLUENZA A VIRUS, INFLUENZA B VIRUS, PYROGENIUM, ACONITUM NAP., ANTIMON. TART., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHAMOMILLA, CINCHONA, EUPATORIUM PERF., FERRUM METALLICUM, GELSEMIUM, HEPAR SULPH.CALC., IODIUM, LACHESIS, MERC. VIV., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SALIX NIGRA, VERBASCUM, APIS MEL., ECHINACEA, HYDRASTISNewton Laboratories, Inc.8f023019-5c58-e0de-e053-2a95a90accfd2025-02-06WarningsExact identifier
ndc (package): 55714-2440-1
ndc (package): 55714-2440-2
ndc (package): 55714-2440-0
ndc (product): 55714-2440
ndc11 (package): 55714244001
ndc11 (package): 55714244000
ndc11 (package): 55714244002
spl id: 2d81b5e1-1ac7-c8c0-e063-6394a90a13fb
spl set id: 8f023019-5c58-e0de-e053-2a95a90accfd

Reported adverse events (FAERS/openFDA)#

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