Umcka Elderberry by Schwabe North America / Schwabe North America, Inc. UMCKA ELDERBERRY syrup

Umcka Elderberry by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Pelargonium sidoides 1x

Aconitum napellus 4x 

Eucalyptus globulus 2x

Sambucus nigra 3x

Bryonia 4x 

Eupatorium perfoliatum 6x 

Gelsemium sempervirens 4x 

Ipecacuanha 3x 

Phosphorus 6x

INACTIVE INGREDIENT

Inactive Ingredients:

Citric acid

Ethyl Alcohol (0.45%)

Elderberry extract

Glycerin

Lactose monohydrate

Maltodextrin

Natural flavor

Purified water

Sorbitol

INDICATIONS & USAGE

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, sneezing, stuffy/runny nose.

DOSAGE & ADMINISTRATION

Directions:

For best results, use at first sign of symptoms.

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

Use only with enclosed dosage cup.

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

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

Children under 6 years of age: consult a physician.

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: a persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, 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 then 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 healthcare professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

PURPOSE

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, sneezing, stuffy/runny nose.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UMCKA ELDERBERRY 
umcka elderberry syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-9845
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)	PELARGONIUM SIDOIDES ROOT	4 [hp_X]  in 120 mL
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
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_X]  in 120 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_X]  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

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: 53499-9845-7	1 in 1 BOX	12/18/2018
1		120 mL 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		05/15/2017

Labeler - Schwabe North America (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-9845)