The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Walgreens Black Elderberry Cold And Flu Relief (NDC 0363-9791). 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, purpose, uses*, warnings, pregnant or breast-feeding, keep out of reach of children, stop use, directions, 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.
Bryonia HPUS - Fever, chills, scratchy throat, muscle soreness
Gelsemium sempervirens HPUS - Sneezing, non-productive cough, bronchial irritation
Sambucus nigra HPUS - Fever, nasal congestion, coughing
Sulphur HPUS - Sinus pressure, sore throat, nasal pressure
Zincum gluconicum HPUS - Nausea, tiredness, exhaustion, bronchial constriction
According to homeopathic indications, these ingredients provide temporary relief of cold and flu symptoms such as: • Nasal and sinus congestion, runny nose, sor 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 phys 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, medical treatment. • Initial worsening of symptoms may occur.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. • In case of overdose, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if:
• You experience worsening symptoms. • Any new symptoms appear. • Symptoms last longer than 7 days.
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 OR chew tablet and swallow. • Do not swallow tablet 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.
• Do not use if blister seal is broken. • Store at room temperature 15o to 30o C (59o to 86o F). • Active ingredients are micro-diluted in accordance with the Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • Retain carton for full drug facts.
Black carrot extract (colorant), Croscarmellose sodium, Elderberry flavor, Lactose, Magnesium stearate, Maltodextrin, Microcrystalline cellulose, Sucrose.
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Carton (Wag Cc 356465 Coldflurelief Box Edited Am)
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