FDA.reportPublic FDA data

Fever Infection

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:54

Label at a glance#

ProductFever Infection
Active ingredientInfluenza A Virus, Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Camphor (natural), Artemisia Cina Pre-flowering Top, Cinchona Officinalis Bark, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Calcium Sulfide, Strychnos Ignatii Seed, Sodium Chloride, Strychnos Nux-vomica Seed, Phosphorus, Pulsatilla Vulgaris, Salix Nigra Bark, Veratrum Viride Root, Matricaria Recutita, Echinacea, Unspecified, Goldenseal, Ferrosoferric Phosphate, Influenza B Virus
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.   Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 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 health care professional.

OTC - ACTIVE INGREDIENT SECTION

Influenzinum 30x, Aconitum nap. 15x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Camphora 15x, Cina 15x, Cinchona 15x, Eupatorium perf. 15x, Ferrum phosphoricum 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Ignatia 15x, Nat. mur.15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Veratrum viride 15x, Chamomilla 3x, Echinacea 3x, Hydrastis 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as chills, aches, sweating, fatigue, 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 p. regnant, 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
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-1503-02020-01-31C16284748780-19d75b9d0-c268-f424-e053-dadaa90a57ceFever - Infection
55714-1503-12020-01-31C16284748780-19d75b9d0-c268-f424-e053-dadaa90a57ceFever - Infection
55714-1503-22020-01-31C16284748780-19d75b9d0-c268-f424-e053-dadaa90a57ceFever - Infection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1503-0Fever Infection.5 mL in 1 BOTTLE, GLASSLIQUID.51
55714-1503-1Fever Infection29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-1503-2Fever Infection59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1503FEVER INFECTION (INFLUENZINUM, ACONITUM NAP., ARSENICUM ALB., BELLADONNA, BRYONIA, CAMPHORA, CINA, CINCHONA, EUPATORIUM PERF., FERRUM PHOSPHORICUM, GELSEMIUM, HEPAR SULPH. CALC., IGNATIA, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, SALIX NIGRA,VERATRUM VIRIDE, CHAMOMILLA, ECHINACEA, HYDRASTIS.) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 3 package rows20130827_4ad7fd42-9920-ee07-d076-b4f191608c4f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Artemisia Cina Pre-flowering TopACTIVE INGREDIENT28M1820ACT1
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q1
Camphor (natural)ACTIVE INGREDIENTN20HL7Q9411
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Eupatorium Perfoliatum Flowering TopACTIVE INGREDIENT1W0775VX6E1
Ferrosoferric PhosphateACTIVE INGREDIENT91GQH8I5F71
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
Influenza A VirusACTIVE INGREDIENTR9HH0NDE2E1
Influenza B VirusACTIVE INGREDIENT1314JZ2X6W1
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Salix Nigra BarkACTIVE INGREDIENTQU52J3A5B31
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X1
Strychnos Ignatii SeedACTIVE INGREDIENT1NM3M2487K1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Veratrum Viride RootACTIVE INGREDIENT197B3Q7T5Q1
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Artemisia Cina Pre-flowering TopACTIVE MOIETY28M1820ACT1
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Calcium SulfideACTIVE MOIETY1MBW07J51Q1
Camphor (natural)ACTIVE MOIETYN20HL7Q9411
Chloride IonACTIVE MOIETYQ32ZN486981
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Eupatorium Perfoliatum Flowering TopACTIVE MOIETY1W0775VX6E1
Ferrosoferric PhosphateACTIVE MOIETY91GQH8I5F71
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q1
GoldensealACTIVE MOIETYZW3Z11D0JV1
Influenza A VirusACTIVE MOIETYR9HH0NDE2E1
Influenza B VirusACTIVE MOIETY1314JZ2X6W1
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ1
PhosphorusACTIVE MOIETY27YLU75U4W1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Salix Nigra BarkACTIVE MOIETYQU52J3A5B31
Strychnos Ignatii SeedACTIVE MOIETY1NM3M2487K1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Veratrum Viride RootACTIVE MOIETY197B3Q7T5Q1
AlcoholINACTIVE INGREDIENT3K9958V90M1

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
55714-150355714-1503-1, 55714-1503-2, 55714-1503-0

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
Influenza A VirusR9HH0NDE2EACTIB
Aconitum NapellusU0NQ8555JDACTIB
Arsenic TrioxideS7V92P67HOACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Camphor (natural)N20HL7Q941ACTIB
Artemisia Cina Pre-flowering Top28M1820ACTACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Eupatorium Perfoliatum Flowering Top1W0775VX6EACTIB
Gelsemium Sempervirens Root639KR60Q1QACTIB
Calcium Sulfide1MBW07J51QACTIB
Strychnos Ignatii Seed1NM3M2487KACTIB
Sodium Chloride451W47IQ8XACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Salix Nigra BarkQU52J3A5B3ACTIB
Veratrum Viride Root197B3Q7T5QACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
GoldensealZW3Z11D0JVACTIB
Ferrosoferric Phosphate91GQH8I5F7ACTIB
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 / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact 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
a99f90e9-d3f8-8fa3-65f8-d531448a33aa4ad7fd42-9920-ee07-d076-b4f191608c4f2011-03-01WarningsExact identifier
spl id: a99f90e9-d3f8-8fa3-65f8-d531448a33aa
spl set id: 4ad7fd42-9920-ee07-d076-b4f191608c4f

Reported adverse events (FAERS/openFDA)#

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