UMCKA ELDERBERRY- umcka elderberry syrup 
Schwabe North America

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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Umcka Elderberry

Active Ingredients:

Aconitum napellus 4x 

Bryonia alba 4x 

Eucalyptus globulus 2x 

Eupatorium perfoliatum 2x 

Gelsemium sempervirens 4x 

Ipecacuanha 3x 

Pelargonium sidoides 1x

Phosphorus 6x

Sambucus nigra 3x

Inactive Ingredients:

Alcohol (0.45%)

Citric acid

Elderberry extract

Lactose

Maltodextrin

Natural Raspberry flavor

Purified water

Sorbitol

Vegetable-source glycerin

Purpose:

Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations.

Directions:

For best results, use at first sign of symptoms.

Continue to use for an additional 48 hours after symptoms cease.

Adults and children 12 years of age and older: take 1 1/2 teaspoons (7.5 mL) three times daily.

Children 6 to 11 years of age: take 1 teaspoon (5mL) three times daily.

Children under 6 years of age: consult a doctor.

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 that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema, a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if: new symptoms occur, symptoms get worse or last more then 7 days, cough lasts more then 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Purpose:

Temporarily relieves flu symptoms. Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations:

chills/fever, congestion, cough, headache, hoarseness, minor aches/pains, sore throat, stuffy nose, sneezing/runny nose

UMCKA Elderberry Intensive Cold + Flue Syrup

UMCKA 15845_CF_ELDERBERRY_05.jpgUMCKA 15845_CF_ELDERBERRY_05.jpg

UMCKA ELDERBERRY 
umcka elderberry syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-5845
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
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 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
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 2 [hp_X]  in 120 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X]  in 120 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 3 [hp_X]  in 120 mL
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT 1 [hp_X]  in 120 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 6 [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
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY (RASPBERRY AND ELDERBERRY FLAVOR) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53499-5845-4 1 in 1 BOX 10/01/2012
1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:53499-5845-7 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2012 09/30/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/01/2012
Labeler - Schwabe North America (831153908)
Establishment
Name Address ID/FEI Business Operations
Schwabe North America 831153908 manufacture(53499-5845)

Revised: 2/2017
Document Id: c0ea6ce2-672d-4f16-9d1a-c40e17aafc5a
Set id: 5e2af06b-a40e-46da-b77e-ea1c09a44a45
Version: 4
Effective Time: 20170220
 
Schwabe North America