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

Sambucol Cold and Flu Relief by

Drug Labeling and Warnings

Sambucol Cold and Flu Relief by is a Homeopathic medication manufactured, distributed, or labeled by PharmaCare US, Inc., Nutritional Laboratories International Inc, Ion Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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.

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

• 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.

PRINCIPAL DISPLAY PANEL

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:

• Nasal & sinus congestion
• Runny nose
• Sore throat
• Coughing
• Sneezing

90 Tablets

Homeopathic

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52053-0001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]  in 1 mg
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	3 [hp_X]  in 1 mg
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]  in 1 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	2 [hp_X]  in 1 mg
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	purple (off purple off grey color with specks)	Score	no score
Shape	ROUND	Size	10mm
Flavor	BERRY (Elderberry)	Imprint Code	SCF
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52053-0001-4	6 in 1 CARTON	10/15/2021
1		4500 mg in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/15/2021

Labeler - PharmaCare US, Inc. (026889965)

Establishment
Name	Address	ID/FEI	Business Operations
Nutritional Laboratories International Inc		007306970	manufacture(52053-0001)

Establishment
Name	Address	ID/FEI	Business Operations
Ion Labs Inc		106499791	pack(52053-0001)