Coldsi 2406l

Coldsi 2406l
SPL v4
SPL
SPL Set ID 7a40e3b3-baa7-3ce8-e053-2991aa0a4d07
Route
ORAL
Published
Effective Date 2022-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sinusitisinum (16 [hp_X]) Influenza A Virus (30 [hp_X]) American Ginseng (15 [hp_X]) Arsenic Cation (3+) (15 [hp_C]) Bryonia Alba Root (6 [hp_X]) Euphrasia Stricta Gaultheria Procumbens Top Gelsemium Sempervirens Root Calcium Sulfide Histamine Goldenseal Dichromate Ion Mercury Phosphorus Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Schoenocaulon Officinale Seed Sage Lobaria Pulmonaria Verbascum Thapsus Echinacea, Unspecified Influenza B Virus
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-11-09 Until 2019-08-01

Description

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Purpose

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.


Medication Information

Purpose

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Description

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Package Label

Warnings Section

WARNGINGS: 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 doctror. 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 runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Dosage & Administration Section

Ages 12 and up, take 6 drops by mouth (ages 4 to 11, give 3 drops) as needed or as directed by a health professional. Under age 4, consult a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Hydrastis 6x, Aralia quin. 15x, Arsenicum alb. 15x, Bryonia 15x, Euphrasia 15x, Gaultheria 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Sabadilla 15x, Salvia 15x, Sticta 15x, Verbascum 15x, Sinusitisinum 16x, 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

Keep out of reach of children.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

WARNGINGS: 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 doctror. 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 runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Ages 12 and up, take 6 drops by mouth (ages 4 to 11, give 3 drops) as needed or as directed by a health professional. Under age 4, consult 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, Hydrastis 6x, Aralia quin. 15x, Arsenicum alb. 15x, Bryonia 15x, Euphrasia 15x, Gaultheria 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Sabadilla 15x, Salvia 15x, Sticta 15x, Verbascum 15x, Sinusitisinum 16x, 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)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)