Cold 4767l

Cold 4767l
SPL v3
SPL
SPL Set ID 98e7a385-aa56-f5fe-e053-2995a90a84d3
Route
ORAL
Published
Effective Date 2022-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Influenza A Virus (30 [hp_X]) Antimony Cation (3+) (15 [hp_X]) Arsenic Cation (3+) (6 [hp_X]) Bryonia Alba Root Chelidonium Majus Cinchona Officinalis Bark Drosera Anglica Eucalyptus Gum Histamine Goldenseal Dichromate Ion Carbonate Ion Iodide Ion Myrrh Sodium Sulfate Anhydrous Strychnos Nux-vomica Seed Phosphorus Pulsatilla Vulgaris Rumex Crispus Root Sambucus Nigra Flowering Top Spongia Officinalis Skeleton, Roasted Tussilago Farfara Verbascum Thapsus Echinacea, Unspecified Arctium Lappa Root Influenza B Virus
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02

Description

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Purpose

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.


Medication Information

Purpose

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Description

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

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 coughs associated with allergies, post-nasal drip, croup and colds.

Inactive Ingredient Section

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

Indications & Usage Section

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Dosage & Administration Section

Directions: 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.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Lappa 6x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Chelidonium majus 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Rumex crisp. 15x, Sambucus nig.15x, Spongia 15x, Tussilago farfara 15x, Verbascum 15x, Influenzinum 30x.

Otc Pregnancy Or Breast Feeding Section

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 coughs associated with allergies, post-nasal drip, croup and colds.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: 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.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Lappa 6x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Chelidonium majus 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Rumex crisp. 15x, Sambucus nig.15x, Spongia 15x, Tussilago farfara 15x, Verbascum 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.


Advanced Ingredient Data


Raw Label Data

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