FDA.reportPublic FDA data

Fever - Infection

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:39

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

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

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare 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 healthcare professional.

OTC - ACTIVE INGREDIENT SECTION

Anthracinum 30x, Influenzinum 30x, Pyrogenium 30x, 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, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Salix nig. 15x, Verbascum 15x, Apis mel. 3x, Echinacea 3x, Hydrastis 3x.

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 dispensing alcohol 20%.  

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-8009-12020-01-31C16284748780-19d75b9d0-d2d6-f424-e053-dadaa90a57ceFever - Infection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-8009-1Fever - Infection29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-8009FEVER - 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.]1Legacy NDC, 1 package rows20140429_2d6665aa-cb69-2321-4d50-37c8710b0b27.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Antimony Potassium TartrateACTIVE INGREDIENTDL6OZ476V31
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Arnica MontanaACTIVE INGREDIENTO80TY208ZW1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
Bacillus Anthracis Immunoserum RabbitACTIVE INGREDIENT41LZ22DD4N1
Baptisia TinctoriaACTIVE INGREDIENT5K1UO2888Y1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Eupatorium Perfoliatum Flowering TopACTIVE INGREDIENT1W0775VX6E1
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
Influenza A VirusACTIVE INGREDIENTR9HH0NDE2E1
Influenza B VirusACTIVE INGREDIENT1314JZ2X6W1
IodineACTIVE INGREDIENT9679TC07X41
IronACTIVE INGREDIENTE1UOL152H71
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT1
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
MercuryACTIVE INGREDIENTFXS1BY2PGL1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Rancid BeefACTIVE INGREDIENT29SUH5R3HU1
Salix Nigra BarkACTIVE INGREDIENTQU52J3A5B31
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1721
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
Antimony Cation (3+)ACTIVE MOIETY069647RPT51
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Arnica MontanaACTIVE MOIETYO80TY208ZW1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
Bacillus Anthracis Immunoserum RabbitACTIVE MOIETY41LZ22DD4N1
Baptisia TinctoriaACTIVE MOIETY5K1UO2888Y1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Calcium SulfideACTIVE MOIETY1MBW07J51Q1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Eupatorium Perfoliatum Flowering TopACTIVE MOIETY1W0775VX6E1
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q1
GoldensealACTIVE MOIETYZW3Z11D0JV1
Influenza A VirusACTIVE MOIETYR9HH0NDE2E1
Influenza B VirusACTIVE MOIETY1314JZ2X6W1
IodineACTIVE MOIETY9679TC07X41
IronACTIVE MOIETYE1UOL152H71
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT1
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
MercuryACTIVE MOIETYFXS1BY2PGL1
PhosphorusACTIVE MOIETY27YLU75U4W1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Rancid BeefACTIVE MOIETY29SUH5R3HU1
Salix Nigra BarkACTIVE MOIETYQU52J3A5B31
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Verbascum ThapsusACTIVE MOIETYC9TD27U1721
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-800955714-8009-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
Bacillus Anthracis Immunoserum Rabbit41LZ22DD4NACTIB
Influenza A VirusR9HH0NDE2EACTIB
Rancid Beef29SUH5R3HUACTIB
Aconitum NapellusU0NQ8555JDACTIB
Antimony Potassium TartrateDL6OZ476V3ACTIM
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIM
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
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates

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
5769c34d-ff42-67a2-4e09-31ea791308442d6665aa-cb69-2321-4d50-37c8710b0b272014-04-15WarningsExact identifier
spl id: 5769c34d-ff42-67a2-4e09-31ea79130844
spl set id: 2d6665aa-cb69-2321-4d50-37c8710b0b27

Reported adverse events (FAERS/openFDA)#

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