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NDC 52053-0004-01 Sambucol Cold and Flu Relief 6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg Details

Sambucol Cold and Flu Relief 6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg

Sambucol Cold and Flu Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by PharmaCare US, Inc.. The primary component is BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; ZINC GLUCONATE.

Product Information

NDC	52053-0004
Product ID	52053-0004_4965b936-5b69-4de6-a5c5-b127c922423a
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sambucol Cold and Flu Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	6; 6; 3; 12; 2
Active Ingredient Units	[hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg
Substance Name	BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; ZINC GLUCONATE
Labeler Name	PharmaCare US, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52053-0004-01 (52053000401)

Pricing Information	N/A
NDC Package Code	52053-0004-1
Billing NDC	52053000401
Package	4 BLISTER PACK in 1 CARTON (52053-0004-1) / 4500 mg in 1 BLISTER PACK (52053-0004-2)
Marketing Start Date	2021-10-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7dace656-ee97-4931-869f-8c8022757abb Details

ACTIVE INGREDIENTS:

Bryonia 6X, Gelsemium Sempervirens 6X, 12X, 30X, Sambucus Nigra 3X, 6X, Sulphur 12X, Zincum Gluconicum 2X, 6X.

INDICATIONS:

•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.

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. Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.

INDICATIONS:

•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.

INACTIVE INGREDIENTS:

Black Carrot Colorant, Croscarmellose Sodium, Elderberry Flavor, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Sucrose.

QUESTIONS:

manufactured exclusively for

PharmaCare US, Inc.

San Diego, CA 92108

Questions? Comments?

Visit our website

www.sambucolUSA.com

or call 1-888-871-9098

PACKAGE LABEL DISPLAY:

NDC 52053-0004-1

Sambucol

BLACK ELDERBERRY

COLD & FLU RELIEF

TAKE AT THE FIRST

SIGN OF COLD AND

FLU SYMPTOMS

Temporary relief from:

Nasal & sinus congestion

Runny nose

Sore Throat

Coughing

Sneezing

60 TABLETS

HOMEOPATHIC

INGREDIENTS AND APPEARANCE

SAMBUCOL COLD AND FLU RELIEF

bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52053-0004
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52053-0004-1	4 in 1 CARTON	10/04/2021
1	NDC:52053-0004-2	4500 mg in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/04/2021

Labeler - PharmaCare US, Inc. (026889965)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(52053-0004) , api manufacture(52053-0004) , label(52053-0004) , pack(52053-0004)

Revised: 6/2022

Document Id: 4965b936-5b69-4de6-a5c5-b127c922423a

Set id: 7dace656-ee97-4931-869f-8c8022757abb

Version: 2

Effective Time: 20220628

Search by Drug Name or NDC

NDC 52053-0004-01 Sambucol Cold and Flu Relief 6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg Details

Sambucol Cold and Flu Relief 6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg

Product Information

Package

Package Images

NDC 52053-0004-01 (52053000401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7dace656-ee97-4931-869f-8c8022757abb Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY:

INGREDIENTS AND APPEARANCE

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