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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

DRUG FACTS:

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)

Sambucol Cold and Flu Night-time syrup

SAMBUCOL COLD AND FLU NIGHT TIME SYRUP 
byronia, chamomilla, gelsemium sempervirens, passiflora incarnata, sambucus nigra, silicea, sulphur, zincum gluconicum, water liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52053-0002
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 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP4 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52053-0002-21 in 1 CARTON09/06/201302/19/2022
1NDC:52053-0002-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/06/201302/19/2022
Labeler - PharmaCare US, Inc. (026889965)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(52053-0002) , api manufacture(52053-0002) , label(52053-0002) , pack(52053-0002)

Revised: 11/2021
 
PharmaCare US, Inc.