Product Name & Indications Section
Cold Cough Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.
Cold Cough
FDA Label NDC 55714-4420
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Cold Cough (NDC 55714-4420). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding product name & indications section, direction section, active ingredient section, purpose section, inactive ingredient section, questions? section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Direction Section
Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.
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.
Purpose Section
Formulated for coughs associated with tonsilitis, allergies, sinusitis, bronchitis, croup, colds and other respiratory conditions.
Inactive Ingredient Section
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.
Questions? Section
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
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.
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
Package Label.
Package Label (R011 L01)
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