UMCKA COUGH ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT- umcka cough syrup

Umcka Cough by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Pelargonium sidoides 1X

Aconitum napellus 3X

Bryonia 3X 

Hepar sulphuris calcareum 6C

Stannum metallicum 6C

Spongia tosta 3X

INACTIVE INGREDIENT

Inactive Ingredients:

Citric acid

English ivy leaf extract

Ethyl Alcohol (0.05%)

glycerin

Lactose Monohydrate

Maltodextrin

Purified water

Sorbitol

INDICATIONS & USAGE

Uses:

Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat, sneezing, stuffy/runny nose. 

Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.

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 (5 mL) 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 physician 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, or is accompanied by excessive phlegm (mucus).

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

These could be a sign of a serious condition.

OVERDOSAGE

Overdose:

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

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:

Keep out of reach of children.  

PURPOSE

Purpose:

Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat, sneezing, stuffy/runny nose.
Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UMCKA COUGH  ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT
umcka cough syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5864
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	1 [hp_X]  in 120 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X]  in 120 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_X]  in 120 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_C]  in 120 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	6 [hp_C]  in 120 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	3 [hp_X]  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5864-4	1 in 1 BOX	10/01/2012
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		10/01/2012

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America		831153908	manufacture(53499-5864)