SAMBUCOL COLD AND FLU RELIEF- bryonia, gelsemium sempervirens, sambucus nigra, sulphur, zincum gluconicum tablet, orally disintegrating

Sambucol Cold and Flu Relief by

Drug Labeling and Warnings

Sambucol Cold and Flu Relief by is a Homeopathic medication manufactured, distributed, or labeled by PharmaCare US, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Active Ingredients (HPUS*) Equal parts in each tablet:

Bryonia 6X, Gelsemium sempervirens 6X, 12X, 30X, Sambucus nigra 3X, 6X, Sulphur 12X, Zincum gluconicum 2X, 6X

*​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

INDICATIONS & USAGE

​Uses**

 ​Temporary relieves cold & flu symptoms

Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and headache.

Also temporary relieves fever, chills, and body aches associated with the flu.

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 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

​Directions

 ​For best results, use at the first sign of symptoms of a cold or flu and continue 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.

OTHER SAFETY INFORMATION

​Other Information

 ​​Do not use if blister seal is broken​Active ingredients are monographed and microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States and are non-toxic and have no known side effects.

INACTIVE INGREDIENT

​Inactive Ingredients

Black Carrot Extract (colorant), Croscarmellose Sodium, Elderberry Flavor, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline Celluclose, Sucrose.

QUESTIONS

​​Sambucol Cold & Flue Relief ​is

manufactured exclusively for

PharmaCare US, Inc.

San Diego, CA 92108

Questions? Comments?

Visit our website

www.sambucolUSA.com

or call 1-888-871-9098

Made in the USA with domestic and imported ingredients.

PRINCIPAL DISPLAY PANEL

NDC: 52053-0003-2

Sambucol

BLACK ELDERBERRY

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

​30 QUICK

​DISSOLVE TABLETS

Bryonia 6X...........................Muscle ache, headache, fevers, chills, dry throat, cough

Gelsemium sempervirens 6X, 12X, 30X.................Bronchial irritation, dry cough, sneezing

Sambucus nigra 3X, 6X....................Nasal congestion, hoarseness, coughing, fever

Sulphur 12X......................Nasal congestion and pressure, headache, burning throat

Zincum gluconicum 2X, 6X.......................Fatigue, nausea, bronchial constriction, minor sore throat

INGREDIENTS AND APPEARANCE

SAMBUCOL COLD AND FLU RELIEF 
bryonia, gelsemium sempervirens, sambucus nigra, sulphur, zincum gluconicum tablet, orally disintegrating

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52053-0003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	3 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)

Product Characteristics
Color	purple (off purple off grey color with specks)	Score	no score
Shape	ROUND	Size	10mm
Flavor	BERRY	Imprint Code	SCF
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52053-0003-2	2 in 1 BOX	12/04/2018
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/04/2018

Labeler - PharmaCare US, Inc. (026889965)