Active Ingredients:
Bryonia 6X, Gelsemium Sempervirens 6X, 12X, 30X, Sambucus Nigra 3X, 6X, Sulphur 12X, Zincum Gluconicum 2X, 6X.
Sambucol Cold And Flu Relief Tablet
FDA Label NDC 52053-0004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacare Us, Inc. for the product Sambucol Cold And Flu Relief (NDC 52053-0004). 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:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications:
•Temporarily relieves cold and flu symptoms.
• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat and
headache.
• Also temporarily relieves fever, chills, and body aches associated with the flu.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
•Temporarily relieves cold and flu symptoms.
• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat and
headache.
• Also temporarily relieves fever, chills, and body aches associated with the flu.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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 using.
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.
Keep Out Of Reach Of Children:
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside.
Adults and children 4 years of age and older. Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.
Children under 4 years of age Consult a doctor before use.
Inactive Ingredients:
Black Carrot Colorant, Croscarmellose Sodium, Elderberry Flavor, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Sucrose.
Questions:
manufactured exclusively for
PharmaCare US Inc.
San Diego CA 92108
Questions? Comments?
Visit our website
www.sambucolUSA.com
or call 1-888-871-9098
Package Label Display:
Sambucol
COLD & FLU RELIEF
TAKE AT THE FIRST
SIGN OF COLD AND
FLU SYMPTOMS
Fast temporary relief from:
Nasal & sinus congestion
Runny nose
Sore Throat
Coughing
Sneezing
Chills & fever
60 QUICK DISSOLVE TABLETS
HOMEOPATHIC
* Please review the disclaimer below.
