The following Structured Product Label (SPL) was submitted to the FDA by Ratis, Llc for the product Cold Armor (NDC 71753-1156). 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 ingredients:, purposes:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each drop) Allium Cepa 6X 12.50%, Hydrastis Canadensis 6X 12.50%, Pulsatilla Pratensis 6X 12.50%, Dulcamara 8x 12.50%, Nux Vomica 8x 12.50%, Ferrum Phosphoricum 12X 12.50%, Gelsemium Sempervirens 12X 12.50%, Kali Bichromicum 12X 12.50%
Allium Cepa – runny nose, sore throat,* Hydrastis Canadensis – thick , yellow mucus,* Pulsatilla Pratensis – cough, chills, loss of taste,* Dulcamara – fever with body pains,* Nux Vomica – nausea, stomachache,* Ferrum Phosphoricum – fever, cough,* Gelsemium Sempervirens – weakness, aches,* Kali Bichromicum – yellow expectoration.*
May temporariy relieve stuffy and runny nose, coughing, congestion, body aches, fever, weakness, and minor sore throat.*
* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.
Stop use and ask a doctor if symptoms persist for more than 2 days.
For oral use only. If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away.
DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING
In case of overdose, get medical help or contact a Poison Control center right away.
• Adults: 2 sprays 3 times a day or as needed
• Children 3-6: 1 spray as above
• Consult a physician for use in children under 6 years of age.
Store in a cool, dry place
Citric acid, demineralized water, ethanol <0.5%, glycerin.
www.HomeopathyStore.com
(888) 405-7551
Dist. by Ratis, LLC
1201 N Orange St,
Ste 7594
Wilmington, DE 19801
LACTOSE FREE
ANNA
KARE
Cold Armor
COLD & COUGH RELIEF*
HOMEOPATHIC ORAL SPRAY
1FL. OZ (30ML)
* Please review the disclaimer below.
