FDA.reportPublic FDA data

Inflammation-Fever

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:51

Label at a glance#

ProductInflammation-Fever
Active ingredientBACILLUS ANTHRACIS IMMUNOSERUM RABBIT, RANCID BEEF, ACONITUM NAPELLUS, ALOE, APIS MELLIFERA, ARNICA MONTANA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BRYONIA ALBA ROOT, LYTTA VESICATORIA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS HORRIDUS VENOM, FERROSOFERRIC PHOSPHATE, GAULTHERIA PROCUMBENS TOP, CALCIUM SULFIDE, IODINE, LACHESIS MUTA VENOM, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, TOXICODENDRON PUBESCENS LEAF, VERATRUM VIRIDE ROOT, VERBASCUM THAPSUS, ECHINACEA, UNSPECIFIED
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as redness, swelling, fever, pain, rash and fatigue.

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.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mellifica 11x, Echinacea 11x, Aconitum napellus 20x, Aloe 20x, Apis mellifica 20x, Arnica montana 20x, Arsenicum album 20x, Baptisia tinctoria 20x, Belladonna 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Crotalus horridus 20x, Ferrum phosphoricum 20x, Gaultheria procumbens 20x, Hepar sulphuris calcareum 20x, Iodium 20x, Lachesis mutus 20x, Nux vomica 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Veratrum viride 20x, Verbascum thapsus 20x, Anthracinum 35x, Pyrogenium 35x.

OTC - PURPOSE SECTION

Formulated for symptoms such as redness, swelling, fever, pain, rash and fatigue.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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

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
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
55714-4760-1Inflammation-Fever30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4760INFLAMMATION-FEVER (ANTHRACINUM, PYROGENIUM, ACONITUM NAP., ALOE, APIS MEL., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, FERRUM PHOSPHORICUM, GAULTHERIA PROCUMBENS, HEPAR SULPH. CALC., IODIUM, LACHESIS, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, VERATRUM VIRIDE, VERBASCUM, ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201205_995c5553-5af7-5a0e-e053-2995a90a6c5c.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-476055714-4760-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB
RANCID BEEF29SUH5R3HUACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ALOEV5VD430YW9ACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
GAULTHERIA PROCUMBENS TOP830295X963ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
IODINE9679TC07X4ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
VERATRUM VIRIDE ROOT197B3Q7T5QACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
WATER059QF0KO0RIACT

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
Inflammation-FeverANTHRACINUM, PYROGENIUM, ACONITUM NAP., ALOE, APIS MEL., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, FERRUM PHOSPHORICUM, GAULTHERIA PROCUMBENS, HEPAR SULPH. CALC., IODIUM, LACHESIS, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, VERATRUM VIRIDE, VERBASCUM, ECHINACEANewton Laboratories, Inc.995c5553-5af7-5a0e-e053-2995a90a6c5c2020-12-04WarningsExact identifier
ndc (package): 55714-4760-1
ndc (product): 55714-4760
ndc11 (package): 55714476001
spl id: b5a82541-b1ac-6fe7-e053-2a95a90a2a25
spl set id: 995c5553-5af7-5a0e-e053-2995a90a6c5c

Reported adverse events (FAERS/openFDA)#

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