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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Sambucol Cold and Flu Relief

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.

Uses

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 the 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

​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.

NDC# 52053-0001-4

Sambucol

Black Elderberry

Cold & Flu Relief

90 Count Family Pack

Take at the first sign of cold and flu symptoms

**Temporary relief from:

90 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
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]  in 1 mg
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
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:52053-0001-46 in 1 CARTON10/15/2021
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 homeopathic10/15/2021
Labeler - PharmaCare US, Inc. (026889965)
Establishment
NameAddressID/FEIBusiness Operations
Nutritional Laboratories International Inc007306970manufacture(52053-0001)
Establishment
NameAddressID/FEIBusiness Operations
Ion Labs Inc106499791pack(52053-0001)

Revised: 4/2022
Document Id: dc7af5e5-755b-1b40-e053-2995a90a54e1
Set id: ce66e57d-ae46-0973-e053-2a95a90a6165
Version: 2
Effective Time: 20220412
 
PharmaCare US, Inc.