Influenza 4821l

Influenza 4821l
SPL v2
SPL
SPL Set ID 995ca26b-7afb-b8d4-e053-2a95a90a7d1a
Route
ORAL
Published
Effective Date 2019-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Influenza A Virus (35 [hp_X]) Histamine (20 [hp_X]) Aconitum Napellus (15 [hp_X]) American Ginseng (11 [hp_X]) Arsenic Cation (3+) Baptisia Tinctoria Root Bryonia Alba Root Cinchona Officinalis Bark Eupatorium Perfoliatum Flowering Top Gelsemium Sempervirens Root Ipecac Carbonate Ion Strychnos Nux-vomica Seed Phosphorus Toxicodendron Pubescens Leaf Echinacea, Unspecified
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, vomiting and cramping.

Purpose

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, vomiting and cramping.


Medication Information

Purpose

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, vomiting and cramping.

Description

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, vomiting and cramping.

Package Label

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

newtonlabs.net – Questions? 800.448.7256

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

Otc Purpose Section

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, vomiting and cramping.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, vomiting and cramping.

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 Echinacea 11x, Aconitum napellus 15x, Aralia quinquefolia 15x, Baptisia tinctoria 15x, Bryonia 15x, Cinchona officinalis 15x, Eupatorium perfoliatum 15x, Gelsemium sempervirens 15x, Ipecacuanha 15x, Kali carbonicum 15x, Phosphorus 15x, Rhus toxicodendron 15x, Arsenicum album 20x, Histaminum hydrochloricum 20x, Nux vomica 20x, Influenzinum 35x.

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.


Structured Label Content

Package Label (PACKAGE LABEL)

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 (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

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

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, vomiting and cramping.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, vomiting and cramping.

Dosage & Administration Section (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 (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 11x, Aconitum napellus 15x, Aralia quinquefolia 15x, Baptisia tinctoria 15x, Bryonia 15x, Cinchona officinalis 15x, Eupatorium perfoliatum 15x, Gelsemium sempervirens 15x, Ipecacuanha 15x, Kali carbonicum 15x, Phosphorus 15x, Rhus toxicodendron 15x, Arsenicum album 20x, Histaminum hydrochloricum 20x, Nux vomica 20x, Influenzinum 35x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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