Flu 2581l

Flu 2581l
SPL v1
SPL
SPL Set ID 115c4835-46e3-3b6f-e063-6394a90a2c80
Route
ORAL
Published
Effective Date 2024-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Histamine (15 [hp_X]) Aconitum Napellus (6 [hp_X]) American Ginseng (35 [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 Influenza A Virus
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-02-14

Description

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

Purpose

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


Medication Information

Purpose

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

Description

Formulated for symptoms associated with colds and flu such as aches, discomfort, fatigue, labored breathing, 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, labored breathing, 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, labored breathing, 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Aconitum nap. 15x, Aralia quin. 15x, Arsenicum alb. 15x, Baptisia 15x, Bryonia 15x, Cinchona 15x, Eupatorium perf. 15x, Gelsemium 15x, Histaminum hydrochloricum 15x, Ipecac. 15x, Kali carb. 15x, Nux vom. 15x, Phos. 15x, Rhus tox. 15x, Influenzinum 35x.

Otc Pregnancy Or Breast Feeding Section

If p regnant 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, labored breathing, 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, labored breathing, 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Aconitum nap. 15x, Aralia quin. 15x, Arsenicum alb. 15x, Baptisia 15x, Bryonia 15x, Cinchona 15x, Eupatorium perf. 15x, Gelsemium 15x, Histaminum hydrochloricum 15x, Ipecac. 15x, Kali carb. 15x, Nux vom. 15x, Phos. 15x, Rhus tox. 15x, Influenzinum 35x.

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

If p regnant 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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