Post – Vaccination: Homeopathic Product Information

POST — VACCINATION- influenza a virus, influenza b virus, measles virus, human sputum, bordetella pertussis infected, aconitum napellus, aluminum oxide, antimony potassium tartrate, arsenic trioxide, baptisia tinctoria root, 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 and hypericum perforatum liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

OTC — KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 no 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

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

INACTIVE INGREDIENT SECTION

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

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 6, 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

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. Sensitive persons begin with 1 drop and gradually increase to full dose.

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
(click image for full-size original)

POST — 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 liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2572
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS (INFLUENZA A VIRUS) INFLUENZA A VIRUS 30 [hp_X] in 1 mL
INFLUENZA B VIRUS (INFLUENZA B VIRUS) INFLUENZA B VIRUS 30 [hp_X] in 1 mL
MEASLES VIRUS (MEASLES VIRUS) MEASLES VIRUS 30 [hp_X] in 1 mL
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED (HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED) HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED 30 [hp_X] in 1 mL
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 15 [hp_X] in 1 mL
ALUMINUM OXIDE (ALUMINUM OXIDE) ALUMINUM OXIDE 15 [hp_X] in 1 mL
ANTIMONY POTASSIUM TARTRATE (ANTIMONY CATION (3+)) ANTIMONY POTASSIUM TARTRATE 15 [hp_X] in 1 mL
ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL
BAPTISIA TINCTORIA ROOT (BAPTISIA TINCTORIA ROOT) BAPTISIA TINCTORIA ROOT 15 [hp_X] in 1 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 15 [hp_X] in 1 mL
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 mL
CROTALUS HORRIDUS HORRIDUS VENOM (CROTALUS HORRIDUS HORRIDUS VENOM) CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X] in 1 mL
POTASSIUM DICHROMATE (DICHROMATE ION) POTASSIUM DICHROMATE 15 [hp_X] in 1 mL
LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 15 [hp_X] in 1 mL
LEDUM PALUSTRE TWIG (LEDUM PALUSTRE TWIG) LEDUM PALUSTRE TWIG 15 [hp_X] in 1 mL
MERCURY (MERCURY) MERCURY 15 [hp_X] in 1 mL
DAPHNE MEZEREUM BARK (DAPHNE MEZEREUM BARK) DAPHNE MEZEREUM BARK 15 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 15 [hp_X] in 1 mL
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 15 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 15 [hp_X] in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 15 [hp_X] in 1 mL
SULFUR (SULFUR) SULFUR 15 [hp_X] in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (THUJA OCCIDENTALIS LEAFY TWIG) THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X] in 1 mL
BILBERRY (BILBERRY) BILBERRY 15 [hp_X] in 1 mL
APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 6 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55714-2572-1 30 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 05/03/2021
Labeler — Newton Laboratories, Inc. (788793610)
Registrant — Newton Laboratories, Inc. (788793610)
Establishment
Name Address ID/FEI Operations
Newton Laboratories, Inc. 788793610 manufacture (55714-2572)

Revised: 07/2021 Newton Laboratories, Inc.

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