Common Cold
FDA Label NDC 57955-1221

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc for the product Common Cold (NDC 57955-1221). 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, inactive ingredients, directions, purpose, warnings, otc - keep out of reach of children, other information, uses, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

This nasal ge lconains 80% of Arg nit 4X HPUS and 63.5% of equal volumes of each of the remaining HPUS ingredients in 10X, 30X, and 1LM potencies, unless otherwise noted.

Argentum nitricum, Argentum iodatum, Argentum metallicum, Argentum muriaticum, Argentum oxydatum, Argentum phosphoricum, Echinacea, Enchinacea purpurea, Gelsemium sempervirens, Pulsatilla, Sabadilla, Scilla maritima, Senega officinalis

Inactive Ingredients

Aloe barbadensis leaf juice, Betula lenta bark oil, Bio-Energetically Enhanced pure water, Eucalyptus globulus leaf oil, glycerin, sodium cocoyl glutamate, sodiumhyaluronate, steviol, xanthan gum, Zingiber officinale (ginger) root oil. 

Directions

Adults and children 12 years of age and older(with adult supervision): 1-2 sprays per nostril 3 times a day.

Initially, depress pumountil primed. Place tip of nozzle just past nasal opening (approx 1/8") While inside nasal opening, slightly angle nozzle outward. Pump 1 to 2 times into each nostril. After application, press lightly on on outside of each nostril for about 5 seconds. Sniff deeply. Wipe nozzle clean after use. Under 12 years of age: consult a healthcare professional before using.

Purpose

Argentum nitricum (30X, 1LM)............congestion, loss of smell, fever

Argentum iodatum.............................hoarseness

Argentum metallicum..........................mucus, stuffy nose, sneezing

Argentum muriaticum.........................headache

Argentum oxydatum...........................nausea, mucus membrane affections

Argentum phosphoricum.....................swelling

Echinacea.........................................raw and sore nostrils

Enchinacea purpurea..........................nasal congestion, fever

Gelsemium sempervirens....................weakness, achiness, fatigue, chills

Pulsatilla...........................................cough, loss of smell, sore nose

Sabadilla...........................................sneezing, sore throat

Scilla maritima...................................runny nose

Senega officinalis................................headache

Warnings

For nasal use only. Ask a doctor before use if you have had recent nose ulcers or surgery, have had a nose injury that has not healed. When using this product, use of spray by more than one person may spread infection. Clean tip after use temporary discomfort such as minor burning, stinging, sneezing or an increase in nasal discharge may occur. Stop use and ask a doctor, if symptoms persist or worsen. Ifpregnant or breast-feeding, ask a healthcare professional before use.Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 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. 

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Information

This product is intended to compliment not replace, standard medical care. Tamper resistant for your protection. Use only if safety seal is intact. Store at room temperature.

Uses

for the temporary relief of symptoms sucha as: 

runny nose, congestion, loss of smell, sneezing, coughing, headaches, fever, chills, sore throat, general weakness, achiness, nausea, fatigue

as per various homeopathis materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

* Please review the disclaimer below.