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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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SAMBUCUS FLUCARE LOZENGES

ACTIVE INGREDIENTS: 

Aconitum napellus 4X

Bryonia alba 4X

Eucalyptus globulus 2X

Eupatorium perfoliatum 2X

Gelsemium sempervirens 4X

Ipecacuanha 3X

Phosphorus 6X

Sambucus nigra 3X

INACTIVE INGREDIENT: European Elderberry extract, fructose, lactose monohydrate, magnesium stearate, malic acid, manitol, natural flavors, silica, sorbitol, sucrose.

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 doctor.

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:

Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied by a  high fever, headache, rash, nausea, vomiting, or a rash, consult a doctor promptly.

 Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma or emphysema; a cough 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, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 day.

These could be signs of a serious condition.

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

Keep out of reach of children.

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

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:

Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied by a  high fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma or emphysema; a cough 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, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 day.

hese could be signs of a serious condition.

Overdosage:

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

Purpose:

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

15799 Sambucus FluCare  (30 Lozenges)

15799 Sambucus FluCare Loz_04.jpg

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5799
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS4 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT4 [hp_X]
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF2 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_X]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP3 [hp_X]
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP2 [hp_X]
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScoreno score
ShapeROUNDSize16mm
FlavorGRAPE (NATURAL GRAPE FLAVOR) Imprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-5799-31 in 1 CARTON10/01/201110/31/2018
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/01/201110/31/2018
Labeler - Schwabe North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc.831153908manufacture(53499-5799)

Revised: 5/2017
 
Schwabe North America, Inc.