Fever 1527l

Fever 1527l
SPL v3
SPL
SPL Set ID 9d762268-8c30-8a86-e053-2a95a90a419c
Route
ORAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Matricaria Chamomilla (6 [hp_X]) Gelsemium Sempervirens Root (15 [hp_X]) Goldenseal (30 [hp_X]) Aconitum Napellus Arsenic Cation (3+) Atropa Belladonna Bryonia Alba Root Camphor (natural) Artemisia Cina Pre-flowering Top Cinchona Officinalis Bark Eupatorium Perfoliatum Flowering Top Ferrosoferric Phosphate Strychnos Ignatii Seed Sodium Cation Strychnos Nux-vomica Seed Phosphorus Anemone Pulsatilla Salix Nigra Bark Veratrum Viride Root Influenza B Virus Influenza A Virus Calcium Sulfide Echinacea, Unspecified
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

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

Indications and Usage

Formuated 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

Indications and Usage

Formuated 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.

Description

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

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

Inactive Ingredient Section

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%

Indications and Usage Section

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

Dosage & Administration Section

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) as needed or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

Warning: If symptoms become severe or fever persists for more than 48 hous, consult a licensed health professional.

Otc Active Ingredient Section

Equal parts of Chamomilla 6x, Echinacea 6x, Hydrastis canadensis 6x, Aconitum napellus 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Camphora 15x, Cina 15x, Cinchona officinalis 15x, Eupatorium perfoliatum 15x, Ferrum phosphoricum 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Ignatia amara 15x, Natrum muriaticum 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Veratrum viride 15x, Influenzinum 30x.

Otc Pregnancy Or Breast Feeding Section

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

Otc Keep Out of Reach of Children 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.


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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%

Indications and Usage Section (INDICATIONS AND USAGE SECTION)

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

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) as needed or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

Warning: If symptoms become severe or fever persists for more than 48 hous, consult a licensed health professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Chamomilla 6x, Echinacea 6x, Hydrastis canadensis 6x, Aconitum napellus 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Camphora 15x, Cina 15x, Cinchona officinalis 15x, Eupatorium perfoliatum 15x, Ferrum phosphoricum 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Ignatia amara 15x, Natrum muriaticum 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Salix nigra 15x, Veratrum viride 15x, Influenzinum 30x.

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)

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.


Advanced Ingredient Data


Raw Label Data

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