Fever - infection

Fever - infection
SPL v1
SPL
SPL Set ID 2d6665aa-cb69-2321-4d50-37c8710b0b27
Route
ORAL
Published
Effective Date 2012-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacillus Anthracis Immunoserum Rabbit (30 [hp_X]) Influenza A Virus (15 [hp_X]) Rancid Beef (3 [hp_X]) Aconitum Napellus Antimony Cation (3+) Arnica Montana Arsenic Cation (3+) Baptisia Tinctoria Atropa Belladonna Bryonia Alba Root Lytta Vesicatoria Matricaria Recutita Cinchona Officinalis Bark Eupatorium Perfoliatum Flowering Top Iron Gelsemium Sempervirens Root Calcium Sulfide Iodine Lachesis Muta Venom Mercury Phosphorus Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Salix Nigra Bark Verbascum Thapsus Apis Mellifera Echinacea, Unspecified Goldenseal Influenza B Virus
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-04-15

Description

Fever - Infection   Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite.

Purpose

Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite


Medication Information

Purpose

Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite

Description

Fever - Infection   Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite.

Package Label

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

Questions Section

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section

Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite

Inactive Ingredient Section

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

Indications & Usage Section

Fever - Infection   Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite.

Dosage & Administration Section

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: If symptoms become severe or fever persists for more than 48 hours, consult a licensed healthcare professional.

Otc Active Ingredient Section

Anthracinum 30x, Influenzinum 30x, Pyrogenium 30x, Aconitum nap. 15x, Antimon. tart. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chamomilla 15x, Cinchona 15x, Eupatorium perf. 15x, Ferrum metallicum 15x, Gelsemium 15x, Hepar sulph.calc. 15x, Iodium 15x, Lachesis 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Salix nig. 15x, Verbascum 15x, Apis mel. 3x, Echinacea 3x, Hydrastis 3x.

Otc Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

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)

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Fever - Infection   Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: If symptoms become severe or fever persists for more than 48 hours, consult a licensed healthcare professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Anthracinum 30x, Influenzinum 30x, Pyrogenium 30x, Aconitum nap. 15x, Antimon. tart. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chamomilla 15x, Cinchona 15x, Eupatorium perf. 15x, Ferrum metallicum 15x, Gelsemium 15x, Hepar sulph.calc. 15x, Iodium 15x, Lachesis 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Salix nig. 15x, Verbascum 15x, Apis mel. 3x, Echinacea 3x, Hydrastis 3x.

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

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

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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