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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

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

Sambucol COLD & FLU  RELIEF

SAMBUCOL COLD AND FLU RELIEF 
bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52053-0004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mg
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 mg
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]  in 1 mg
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [hp_X]  in 1 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpurple (off purple off grey color with specks) Scoreno score
ShapeROUNDSize10mm
FlavorBERRY (Elderberry) Imprint Code SCF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52053-0004-14 in 1 CARTON10/04/2021
1NDC:52053-0004-24500 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/04/2021
Labeler - PharmaCare US, Inc. (026889965)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(52053-0004) , api manufacture(52053-0004) , label(52053-0004) , pack(52053-0004)

Revised: 5/2024
Document Id: fc0aa1b5-3fea-406c-b8e3-151531f1c0b8
Set id: 7dace656-ee97-4931-869f-8c8022757abb
Version: 3
Effective Time: 20240524
 
PharmaCare US, Inc.