FDA.reportPublic FDA data

Vaccination - Illness

Manufacturer
Newton Laboratories, Inc.
Effective date
2017-12-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:05:58

Label at a glance#

ProductVaccination - Illness
Active ingredientINFLUENZA A VIRUS, INFLUENZA B VIRUS, MEASLES VIRUS, HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED, ACONITUM NAPELLUS, ALUMINUM OXIDE, ANTIMONY POTASSIUM TARTRATE, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, CROTALUS HORRIDUS HORRIDUS VENOM, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, LACHESIS MUTA VENOM, LEDUM PALUSTRE TWIG, MERCURY, DAPHNE MEZEREUM BARK, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, SULFUR, THUJA OCCIDENTALIS LEAFY TWIG, BILBERRY, APIS MELLIFERA, ECHINACEA, UNSPECIFIED, HYPERICUM PERFORATUM
Label structure9 sections

Label contents#

Full prescribing information#

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Vaccination - Illness Formulated for vaccinations and viral-related symptoms such as headache, site pain, irritability and other reactions.

PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,​ ask a doctor before use.

WARNINGS SECTION

Warning: Keep out of reach of children. Do not use ​if tamper-evident seal is broken or missing. If symptoms worsen or persist for more that a few days, consult a doctor. If ​pregnant or breast-feeding, ask a doctor before use.

QUESTIONS? SECTION

OTC - QUESTIONS SECTION

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

Questions? 1.800.448.7256

INACTIVE INGREDIENT SECTION

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

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 3x, Echinacea 3x, Hypericum 3x, Apis mel. 8x, Echinacea 8x, Hypericum 8x, Aconitum nap. 15x, Alumina 15x, Antimon. tart.15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cinchona 15x, Crotalus horridus 15x, Gelsemium 15x, Kali bic. 15x, Lachesis 15x, Ledum 15x, Merc. viv. 15x, Mezereum 15x, Nux vom.15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Silicea 15x, Sulphur 15x, Thuja occ. 15x, Vaccinium 15x, Influenzinum 35x, Morbillinum 35x, Pertussinum 35x.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-463655714-4636-1, 55714-4636-2

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
ALCOHOL3K9958V90MIACT
INFLUENZA A VIRUSR9HH0NDE2EACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
MEASLES VIRUSHT3R7C012QACTIB
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTEDU364V64HUNACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ALUMINUM OXIDELMI26O6933ACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA5K1UO2888YACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
MERCURYFXS1BY2PGLACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SULFUR70FD1KFU70ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
BILBERRY9P2U39H18WACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB

Source Document#

Source XML · Source PDF

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
b6740e98-51cd-60cd-e053-2995a90a830e60b94d5f-b111-e1ea-e053-2a91aa0aad6c2020-12-14WarningsExact identifier
spl set id: 60b94d5f-b111-e1ea-e053-2a91aa0aad6c

Reported adverse events (FAERS/openFDA)#

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