The following Structured Product Label (SPL) was submitted to the FDA by Trp Company for the product Compare2 Black Elderberry Cold And Flu Relief (NDC 17312-077). 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 otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients (In each tablet):
Bryonia 6X HPUS, Gelsemium sempervirens 6X, 12X, 30X HPUS, Sambucus nigra 3X, 6X HPUS, Sulphur 12X HPUS, Zincum gluconicum 2X, 6X HPUS
* The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Uses*
According to homeopathic indications, these ingredients provide temporary relief of cold and flu symptoms such as: • Nasal and sinus congestion, runny nose, sore throat, coughing, sneezing, and chills and fever, after serious causes have been ruled out by a physician. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Warnings
A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 4 years of age unless directed by a physician. • This product is intended to complement, not replace, standard medical treatment. • Initial worsening of symptoms may occur. • A physician should always be consulted to rule out serious causes.
If pregnant or breast feeding, ask a health professional before using.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• Suitable for adults and children ages 4 and over. Children under the age of 4: Consult a physician before use. • For best results, take at the start of the symptoms for cold or flu and continue to take for another 48 hours after the symptoms end. • Dissolve entire tablet under tongue. • Do not chew or swallow whole. • Take 1 tablet every three hours. • Take at least 10 minutes before or at least 10 minutes after eating or drinking. • Homeopathic remedies may not be effective for everyone. Individual results may vary.
Other Information
• Do not use if blister seal is broken. • Store at room temperature 15 o to 30 o C (59 o to 86 o F). • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • Retain carton for full drug facts.
Inactive Ingredients
Black carrot extract (colorant), Croscarmellose sodium, Elderberry flavor, Lactose, Magnesium stearate, Maltodextrin, Microcrystalline cellulose, Sucrose.
NDC 17312-077-30
Carton (Com Pare2 Sambucol Dieline 04 13 20r11f)
Label (Com Pare2 Sambucol Cold)
Bryonia 6X HPUS.................................................Fever, chills, scratchy throat, muscle soreness
Gelsemium sempervirens 6X, 12X, 30X HPUS....Sneezing, non-productive cough, bronchial irritation
Sambucus nigra 3X, 6X HPUS.............................Fever, nasal congestion, coughing
Sulphur 12X HPUS...............................................Sinus pressure, sore throat, nasal pressure
Zincum gluconicum 2X, 6X HPUS........................Nausea, tiredness, exhaustion, bronchial constriction
* Please review the disclaimer below.
