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

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:

(in Each Tablet): Bryonia 6X,* Gelsemium Sempervirens 6X, 12X, 30X,* Sambucus Nigra 3X, 6X,* Sulphur 12X,* Zincum Gluconicum 2X, 6X.*

*Indicates the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States.

PURPOSE:

Bryonia - Muscle ache, headache, dry throat, cough, Gelsemium Sempervirens - Sneezing, Sambucus Nigra - Nasal congestion, coughing, Sulphur - Nasal congestion and pressure, headache, Zincum Gluconicum - Fatigue, nausea, minor sore throat

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:

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:

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 12 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.

INACTIVE INGREDIENTS:

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

QUESTIONS:

Manufactured Exclusively for 

PharmaCare US, Inc.

San Diego, CA 92108

SambucolUSA.com

or call 1-888-871-9098

PACKAGE LABEL DISPLAY:

NDC: 52053-0004-1

Sambucol

BLACK ELDERBERRY

COLD & FLU RELIEF
FAST TEMPORARY RELIEF FROM:
√ NASAL CONGESTION √ SORE THROAT
√ FEVER + CHILLS √ HEADACHE

√ RUNNY NOSE √ COUGH

60 TABLETS

HOMEOPATHIC

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52053-0004
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)
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

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: 52053-0004-1	4 in 1 CARTON	10/04/2021
1	NDC: 52053-0004-2	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		10/04/2021

Labeler - PharmaCare US, Inc. (026889965)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(52053-0004) , api manufacture(52053-0004) , label(52053-0004) , pack(52053-0004)