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

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 INGREDIENTS: 

Elderberry extract

fructose

lactose monohydrate

magnesium stearate

malic acid

manitol

natural flavor

silica

sorbitol

sucrose

DOSAGE & ADMINISTRATION

Dosage and Administration:

Directions: Chew or dissolve lozenges in the mouth.

Do not swallow lozenges whole.

For best results, use at the first sign of symptoms:

Adults and children 12 years of age and older: Take 1 chewable lozenge four times daily.
Children 6-11 years of age: Take 1 chewable lozenges two times daily.
Children under 6 years of age: Consult a physician.

INDICATIONS & USAGE

Indications and Usage:

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

WARNINGS

Warnings:

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

Consult a physician promptly.

Ask a doctor before use if you have a persistent or chronic cough that lasts, is occurs with such as occurs with smoking, asthma 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 day, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a heathcare 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 a persistent or chronic cough that lasts, is occurs with such as occurs with smoking, asthma 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 day, cough lasts more than 7 days or occurs with rash or persistent headache. These could be signs of a serious condition.

OVERDOSAGE

Overdosage:

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

PURPOSE

Purpose:

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

PRINCIPAL DISPLAY PANEL

15799 Sambucus FluCare  (30 Lozenges)

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 lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-9779
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]
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	2 [hp_X]
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	3 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	4 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
FRUCTOSE (UNII: 6YSS42VSEV)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALIC ACID (UNII: 817L1N4CKP)
MANNITOL (UNII: 3OWL53L36A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	purple	Score	no score
Shape	ROUND	Size	16mm
Flavor	GRAPE (NATURAL GRAPE FLAVOR)	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-9779-3	1 in 1 CARTON	09/08/2017
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/08/2017

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-9779)