Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum

FDA Drug Profile — Sambucol Cold and Flu Relief

Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Sambucol Cold and Flu Relief. Available dosage forms: tablet, tablet, orally disintegrating.

Drug Details

Generic Name
Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum
Brand Names
Sambucol Cold and Flu Relief
Application Number
Sponsor
PharmaCare US, Inc.
NDC Codes
2
Dosage Forms
TABLET, TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients
BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, SAMBUCUS NIGRA FLOWERING TOP, SULFUR, ZINC GLUCONATE

Indications and Usage

USES: • Temporarily relieves cold & flu symptoms.** • Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and headache.** • Also temporarily relieves body aches associated with the flu.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

WARNINGS: 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 3 years of age unless directed by a physician. Stop use and ask a doctor if: • Symptoms worsen • Any new symptoms appear. • Fever lasts for more than three days. • Respiratory symptoms persist for more than seven days. 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. Do not use if blister seal is broken. Active Ingredients are monographed and microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States.