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, dry throat, cough

Gelsemium sempervirens 6X, 12X, 30X............................Sneezing

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

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

Zincum gluconicum 2X, 6X..................Fatigue, nausea, 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 and sinus congestion, minor sore throat and headache.

• Also temporarily relieves 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 for children under 4 years of age.

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 use.

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.

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.

INACTIVE INGREDIENTS:

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

QUESTIONS:

PharmaCare US Inc.

P.O. Box 122950

San Diego CA 92112

Questions? Comments?

Visit our website

www.sambucolUSA.com

or call 1-888-871-9098

PACKAGE LABEL DISPLAY:

NDC# 52053-0001-2



Sambucol



BLACK ELDERBERRY



COLD & FLU RELIEF



TAKE AT THE FIRST



SIGN OF COLD AND



FLU SYMPTOMS



**Temporary relief from:



Nasal & sinus congestion



Runny nose



Sore Throat



Coughing



Sneezing



30 TABLETS



HOMEOPATHIC

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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
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)  
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
Document Id: dbe9f79e-4494-3c30-e053-2995a90a933c
Set id: 4dc2088f-3f13-4e49-83e4-44c2a26d195f
Version: 6
Effective Time: 20220405
 
PharmaCare US, Inc.