Fever - infection

Fever - infection
SPL v1
SPL
SPL Set ID 4ad7fd42-9920-ee07-d076-b4f191608c4f
Route
ORAL
Published
Effective Date 2012-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Influenza A Virus (30 [hp_X]) Aconitum Napellus (15 [hp_X]) Arsenic Cation (3+) (3 [hp_X]) Atropa Belladonna Bryonia Alba Root Camphor (natural) Artemisia Cina Pre-flowering Top Cinchona Officinalis Bark Eupatorium Perfoliatum Flowering Top Gelsemium Sempervirens Root Calcium Sulfide Strychnos Ignatii Seed Chloride Ion Strychnos Nux-vomica Seed Phosphorus Pulsatilla Vulgaris Salix Nigra Bark Veratrum Viride Root Matricaria Recutita Echinacea, Unspecified Goldenseal Ferrosoferric Phosphate Influenza B Virus
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.   Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 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 health care professional.

Otc Active Ingredient Section

Influenzinum 30x, Aconitum nap. 15x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Camphora 15x, Cina 15x, Cinchona 15x, Eupatorium perf. 15x, Ferrum phosphoricum 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Ignatia 15x, Nat. mur.15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Veratrum viride 15x, Chamomilla 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 p. regnant, 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 chills, aches, sweating, fatigue, 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 chills, aches, sweating, fatigue, nausea and loss of appetite.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: ORAL USE ONLY - SHAKE WELL.   Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 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 health care professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Influenzinum 30x, Aconitum nap. 15x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Camphora 15x, Cina 15x, Cinchona 15x, Eupatorium perf. 15x, Ferrum phosphoricum 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Ignatia 15x, Nat. mur.15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Veratrum viride 15x, Chamomilla 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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