Cold - cough

Cold - cough
SPL v2
SPL
SPL Set ID b88544ce-50b9-33d9-9cdf-e08f6e012fec
Route
ORAL
Published
Effective Date 2011-12-20
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Influenza A Virus (35 [hp_X]) American Ginseng (20 [hp_X]) Arsenic Cation (3+) (8 [hp_X]) Bryonia Alba Root 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
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-06-01
Description

Cold Cough       Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

Purpose

Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

Medication Information

Purpose

Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

Description

Cold Cough       Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

Package Label.

Purpose Section

Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

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

Active Ingredient Section

Influenzinum 35x, Aralia quinquefolia 20x, Arsenicum alb. 20x, Bryonia 20x, Euphrasia 20x, Gaultheria procumbens 20x, Gelsemium 20x, Hepar sulph. calc. 20x, Histaminum hydrochloricum 20x, Hydrastis 20x, Kali bic. 20x, Merc. viv. 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sabadilla 20x, Salvia 20x, Sticta 20x, Verbascum 20x, Echinacea 8x, Hydrastis 8x, Echinacea 3x, Hydrastis 3x.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage section

Cold Cough      Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

Dosage & Administration section

Directions:   Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.

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.

Keep Out of Reach of Children Section

Keep out of reach of children

Structured Label Content

Package Label. (PACKAGE LABEL.)

Purpose Section (PURPOSE SECTION)

Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

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

Active Ingredient Section (ACTIVE INGREDIENT SECTION)

Influenzinum 35x, Aralia quinquefolia 20x, Arsenicum alb. 20x, Bryonia 20x, Euphrasia 20x, Gaultheria procumbens 20x, Gelsemium 20x, Hepar sulph. calc. 20x, Histaminum hydrochloricum 20x, Hydrastis 20x, Kali bic. 20x, Merc. viv. 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sabadilla 20x, Salvia 20x, Sticta 20x, Verbascum 20x, Echinacea 8x, Hydrastis 8x, Echinacea 3x, Hydrastis 3x.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage section (INDICATIONS & USAGE SECTION)

Cold Cough      Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.

Dosage & Administration section (DOSAGE & ADMINISTRATION SECTION)

Directions:   Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.

Pregnancy Or Breast Feeding Section (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.

Keep Out of Reach of Children Section (KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:15.416303 · Updated: 2026-03-14T23:14:27.680965