SAMBUCOL COLD AND FLU NIGHT TIME SYRUP- byronia, chamomilla, gelsemium sempervirens, passiflora incarnata, sambucus nigra, silicea, sulphur, zincum gluconicum, water liquid

Sambucol Cold and Flu Night Time Syrup by

Drug Labeling and Warnings

Sambucol Cold and Flu Night Time Syrup by is a Otc medication manufactured, distributed, or labeled by PharmaCare US, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Bryonia 6X, Chamomilla 6X, Gelsemium Sempervirens 6X, 12X, 30X, Passiflora Incarnata 6X, Sambucus Nigra 4X, 6X, Silicea 12X, Sulphur 12X, Zincum Gluconicum 3X, Water USP QS.

INDICATIONS:

Temporarily relieves the symptoms of cold and flue while providing a restful night's sleep.

Fast temporary relief from

- Sinus congestion

- Cough

- Aches & pains

- Fever & chills

- Sore throat

- Sleeplessness

- Headache

WARNINGS:

​Sore Throat Warning -​ Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a 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 last for more than three days - Respiratory symptoms persist for more than seven days.

​If pregnant or breast feeding:​ ask a health care 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 bottle seal is broken.

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: Take 1 serving (10 ml) at the onset of symptoms.

-Repeat every three hours until symptoms are gone.

-Children under 4 years of age: Consult a doctor before use.

INDICATIONS:

​Samucol Cold & Flu Night-Time Relief:​

- Safe for the whole family*

- No known drug interactions

- No known side effects

- Pleasant berry taste

- Fast temporary relief from cold & flu symptoms

- Provides a restful night's sleep

- With natural elderberry & zinc

- Unique homeopathic formulation

- Great tasting syrup

- Soothing to the throat

- Non-habit forming

*Children under 4: Consult a doctor before use.

INACTIVE INGREDIENTS:

Citric Acid, Elderberry Natural Flavor, European Elder (Sambucus nigra) Extract, Fructose, Glycerin, Purified Water, Sodium Benzoate, Sorbitol, Xanthan Gum, Zinc Gluconate.

QUESTIONS:

Sambucol is a registered trademark of

PharmaCare Laboratories Pty ltd.

Manufactured for and distributed by

PharmaCare U.S. Inc.

San Diego, CA 92108

Questions? Comments?

Visit our website

www.SambucolUSA.com

or call 1-888-871-9098

PACKAGE DISPLAY LABEL:

Sambucol

Black Elderberry

COLD & FLU

NIGHT-TIME SYRUP

HOMEOPATHIC

4 Fl oz (120 mL)

INGREDIENTS AND APPEARANCE

SAMBUCOL COLD AND FLU NIGHT TIME SYRUP 
byronia, chamomilla, gelsemium sempervirens, passiflora incarnata, sambucus nigra, silicea, sulphur, zincum gluconicum, water liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52053-0002
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 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	4 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)
FRUCTOSE (UNII: 6YSS42VSEV)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52053-0002-2	1 in 1 CARTON
1	NDC: 52053-0002-1	120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/06/2013

Labeler - PharmaCare US, Inc. (026889965)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(52053-0002) , api manufacture(52053-0002) , label(52053-0002) , pack(52053-0002)