FDA.reportPublic FDA data

Post-Vaccination

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-11-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:35

Key Label Information#

Active Ingredients And Purpose

OTC - PURPOSE SECTION

Formulated for vaccination-related and viral-related symptoms such as fever, inflammation, injection site pain, fatigue and skin discomfort.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 6x, Echinacea 6x, Hypericum 6x, Aconitum nap. 15x, Alumina 15x, Antimon. tart.15x, Baptisia 15x, Bryonia 15x, Cinchona 15x, Crotalus horridus 15x, Gelsemium 15x, Kali bic. 15x, Lachesis 15x, Ledum 15x, Merc. viv. 15x, Mezereum 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Silicea 15x, Sulphur 15x, Thuja occ. 15x, Vaccinium 15x, Arsenicum alb. 15x, Belladonna 15x, Nux vom. 15x, Influenzinum 30x, Morbillinum 30x, Pertussinum 30x.

Uses

INDICATIONS & USAGE SECTION

Formulated for vaccination-related and viral-related symptoms such as fever, inflammation, injection site pain, fatigue and skin discomfort.

Warnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) one to four times daily or as directed by a health professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

Other Label Information

QUESTIONS SECTION

newtonlabs.net - Questions? 1.800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

PACKAGE LABEL

Label Images#

F098-P01
F098-P01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-1733-1Post-Vaccination28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-1733POST-VACCINATION (INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201124_90bb15e5-3d9d-e2e2-e053-2995a90a85ac.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-173355714-1733-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
INFLUENZA A VIRUSR9HH0NDE2EACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
MEASLES VIRUSHT3R7C012QACTIB
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTEDU364V64HUNACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ALUMINUM OXIDELMI26O6933ACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
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

Complete SPL Sections#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

WARNINGS SECTION

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? 1.800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Formulated for vaccination-related and viral-related symptoms such as fever, inflammation, injection site pain, fatigue and skin discomfort.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 6x, Echinacea 6x, Hypericum 6x, Aconitum nap. 15x, Alumina 15x, Antimon. tart.15x, Baptisia 15x, Bryonia 15x, Cinchona 15x, Crotalus horridus 15x, Gelsemium 15x, Kali bic. 15x, Lachesis 15x, Ledum 15x, Merc. viv. 15x, Mezereum 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Silicea 15x, Sulphur 15x, Thuja occ. 15x, Vaccinium 15x, Arsenicum alb. 15x, Belladonna 15x, Nux vom. 15x, Influenzinum 30x, Morbillinum 30x, Pertussinum 30x.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) one to four times daily or as directed by a health professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Formulated for vaccination-related and viral-related symptoms such as fever, inflammation, injection site pain, fatigue and skin discomfort.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML