SAMBUCUS FLUCARE- aconitum napellus, bryonia alba root, eucalyptus globulus leaf, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus, sambucus nigra flowering top syrup

Sambucus Flucare by

Drug Labeling and Warnings

Sambucus Flucare by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Aconitum napellus 4X

Eucalyptus globulus 2X

Sambucus nigra 3X

Bryonia 4X

Eupatorium perfoliatum 6X

Gelsemium sempervirens  4X

Phosphorus 6X

Ipecacuanha 3X

INACTIVE INGREDIENT

INACTIVE INGREDIENT:

Citric acid

Elderberry extract

Ethyl Alcohol (0.6%)

Fructose

Glycerin

Lactose Monohydrate

Natural Raspberry flavor

Purified Water

DOSAGE & ADMINISTRATION

Dosage and Administration:

Directions: For best results, use at first sign of symptoms.

Use only with enclosed dosage cup

Adults and children 12 years of age and older: Take 2 teaspoons (tsp) (10 mL) four times daily.
Children 6-11 years of age: take 1 teaspoon (5 mL) four times daily.
Children under 6 years of age: Consult a physician.

INDICATIONS & USAGE

Indication and Usage:

Temporarily relieves common flu symptoms: chills and fevers, congestion, cough, headache, hoarseness, runny nose, sore throat, stuffy nose, sneezing, minor aches and pains.

WARNINGS

Warnings:

Sore throat warning:  Severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash may be serious.

Consult a doctor promptly.

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma or chronic bronchitis or emphysema or is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days; fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

This could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

Pregnancy or Breast Feeding:

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children:

Keep out of reach of children.

Ask the Doctor:

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma or chronic bronchitis or emphysema or is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days; fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

This could be signs of a serious condition.

OVERDOSAGE

Overdose:

In case of overdose, seek medical help or contact a Poison Control Center immediately.

PURPOSE

Purpose:

Temporarily relieves common flu symptoms: chills and fevers, congestion, cough, headache, hoarseness, runny nose, sore throat, stuffy nose, sneezing, minor aches and pains.

Package Label and Principal Display: Sambucus Flucare 15803

INGREDIENTS AND APPEARANCE

SAMBUCUS FLUCARE 
aconitum napellus, bryonia alba root, eucalyptus globulus leaf, eupatorium perfoliatum flowering top, gelsemium sempervirens root, ipecac, phosphorus, sambucus nigra flowering top syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-9803
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	4 [hp_X]  in 120 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	2 [hp_X]  in 120 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	3 [hp_X]  in 120 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	4 [hp_X]  in 120 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]  in 120 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]  in 120 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]  in 120 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_X]  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
ALCOHOL (UNII: 3K9958V90M)
FRUCTOSE (UNII: 6YSS42VSEV)
GLYCERIN (UNII: PDC6A3C0OX)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY (NATURAL RASPBERRY FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-9803-5	1 in 1 BOX	10/03/2017
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/03/2017

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-9803)