Warnings Section
WARNING: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
Cold - Sinus Pellet
FDA Label NDC 55714-2407
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 - Sinus (NDC 55714-2407). 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 warnings section, otc - keep out of reach of children section, otc - pregnancy or breast feeding section, questions section, inactive ingredient section, otc - purpose section, otc - active ingredent section, dosage & administration section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a doctor before use.
Questions Section
newtonlabs.net - Questions? 800.448.7256
Newtton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
Inactive Ingredient Section
Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
Otc - Purpose Section
Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.
Otc - Active Ingredent 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.
Dosage & Administration Section
Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush or dissolve pellets in purfied water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
Indications & Usage Section
Formulated for associated symptoms such as runny nose, watery eyes, congestion, pain, sinus pressure, post-nasal drip, cough and inflammation.
Package Label
Package Label (N003 P01)
* Please review the disclaimer below.
