Active Ingredient
Allium Cepa 5C - Euphrasia Officinalis 5C - Hydrastis Canadensis 5C - Nux Vomica 5C - Pulsatilla 5C - Rumex Crispus 5C – Sabadilla 5C - Sambucus Nigra 5C.
Cold Comfort Spray
FDA Label NDC 76472-7003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sevene Usa for the product Cold Comfort (NDC 76472-7003). 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 active ingredient, traditionally used for, directions, use, warnings, otc - keep out of reach of children, storage and handling, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Traditionally Used For
This homeopathic medicine is made from a combination of ingredients traditionally used to relieve symptoms of:
- Mild Dry Teasing Cough
- Runny, Stuffy, Congested, Nose with Watery, Thick, or Yellow Discharges
- Loss Of Smell
- Sneezing
Directions
Adults/Children above 6 : spray 2 shots directly under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Use
ALLIUM CEPA
Runny Nose with Clear Discharge - Sneezing - Watery Eyes .*
EUPHRASIA OFFICINALIS
Allergies with Abundant and Irritating Eye Discharge .*
HYDRASTIS CANADENSIS
Postnasal Drip - Stomach Ache with Constipation .*
NUX VOMICA
Indigestion, Heartburn, Drowsiness, Nausea from Overindulgence/Overeating .*
PULSATILLA
Ocular or Nasal Yellow Discharge Associated with Cold .*
RUMEX CRISPUS
Dry, Tickling, Persistent Cough Worsened by Cold Air .*
SABADILLA
Allergic Rhinitis (Hay Fever): Frequent Sneezing, Runny Nose, Nasal Itching, and Watery Eyes .*
SAMBUCUS NIGRA
Respiratory Disorders: Nasal congestion - Spasmodic/Suffocative Cough (nocturnal) - Croup - Asthma-like breathing difficulties .*
Warnings
Consult a physician for use in children under 6 years of age.
Contact a doctor if symptoms persist.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Storage And Handling
Store at 59-77°F.
Otc - Do Not Use
Do not use if seal is broken or missing.
Inactive Ingredient
Organic Alcohol 20%
Purified Water
Questions?
Distributed by Sevene USA
East Troy, WI 53120 USA
1-855 - OLLOMED
QUESTIONS? [email protected]
www.ollois.com
MADE IN FRANCE.
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. No guarantee to be effective. A homeopathic dilution may not to be susceptible to scientific measurement. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
* Please review the disclaimer below.
