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.

----------

DRUG FACTS:

ACTIVE INGREDIENTS:

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

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

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. 

Active Ingredients are monographed and microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States.

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.

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# 52053-0001-2
Sambucol®
BLACK ELDERBERRY
COLD & FLU RELIEF

FAST TEMPORARY RELIEF FROM:

√ NASAL CONGESTION  √ SORE THROAT

√ FEVER + CHILLS √ HEADACHE

√ RUNNY NOSE  √ COUGH


30 TABLETS


HOMEOPATHIC

Sambucol

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)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
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: 8/2023
Document Id: 7f04a1a2-cf94-4664-9815-463e121204d2
Set id: 4dc2088f-3f13-4e49-83e4-44c2a26d195f
Version: 9
Effective Time: 20230815
 
PharmaCare US, Inc.