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

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

PURPOSE:

Bryonia 6X..............Muscle ache, headache, fever, 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

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

INDICATIONS:

• Temporarily relieves cold and flu symptoms.

• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & 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 4 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:

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 4years of age: Consult a doctor before use.

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 INGREDIENTS:

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

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

1

SAMBUCOL COLD AND FLU RELIEF 
bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52053-0001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [hp_X]  in 1 mg
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
Inactive Ingredients
Ingredient NameStrength
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)  
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:52053-0001-22 in 1 CARTON06/30/2017
1NDC:52053-0001-14500 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/26/2013
Labeler - PharmaCare US, Inc. (026889965)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(52053-0001) , api manufacture(52053-0001) , label(52053-0001) , pack(52053-0001)

Revised: 4/2022
 
PharmaCare US, Inc.