SAMBUCOL COLD AND FLU RELIEF- bryonia, gelsemium sempervirens, sabucus 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., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Bryonia 6X, Gelsemium Sempervirens 6X, 12X, 30X, Sambucus Nigra 3X, 6X, Sulphur 12X, Zincum Gluconicum 2X, 6X.

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.

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. 

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 until symptoms are gone. Children under 4 years of age consult a doctor before use. 

INACTIVE INGREDIENTS:

Black Carrot Colorant, Natural, Croscarmellose Sodium, Elderberry Flavor, Natural, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Sucrose

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.

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.

QUESTIONS:

PharmaCare US Inc.

P.O. Box 122950

San Diego CA  92112

Questions? Comments?

Visit our website

www.sambucolUSA.com

or call 1-866-613-5057

PACKAGE LABEL DISPLAY:

NDC# 52053-0001-2
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
HOMEOPATHIC

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52053-0001
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]  in 1 mg
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]  in 1 mg
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	3 [hp_X]  in 1 mg
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	2 [hp_X]  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE (UNII: J2B2A4N98G)
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 (Elderberry)	Imprint Code	SCF
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52053-0001-2	2 in 1 CARTON	06/30/2017
1	NDC: 52053-0001-1	4500 mg 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		03/26/2013

Labeler - PharmaCare US, Inc. (026889965)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(52053-0001) , api manufacture(52053-0001) , label(52053-0001) , pack(52053-0001)