UMCKA COLDCARE CHILDRENS CHERRY- pelargonium sidoides syrup

Umcka ColdCare Childrens Cherry by

Drug Labeling and Warnings

Umcka ColdCare Childrens Cherry 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 Ingredient:

PELARGONIUM SIDOIDES 1X

Inactive Ingredients:

ARONIA  JUICE

CITRIC ACID

ALCOHOL (0.05%)

FRUCTOSE

MALTODEXTRIN

NATURAL CHERRY FLAVOR

POTASSIUM CITRATE

PURIFIED WATER

POTASSIUM SORBATE

DOSAGE & ADMINISTRATION

Dosage and Administration:

Nature's Way Brand:

Directions:

For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. 

Use only with enclosed dosage cup.

Children 12 years of age and older: Take 1.5 teaspoons (7.5mL) three times daily.
Children 6-11 years of age: Take 1 teaspoon (5mL) three times daily.
Children under 6 years of age: Ask a physician.

Indications and Usage:

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat. 

Purpose:

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat.

WARNINGS

Warnings: 

Sore throat warning: Severe or persistent sore throat for more than 2 days of 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 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 in 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 signs of a serious condition.

Keep Out of Reach of Children:

Keep out of the reach of children.

Ask the Doctor:

Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with 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 in 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

Pregnancy or Breast Feeding:

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

Overdosage:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UMCKA COLDCARE CHILDRENS CHERRY 
pelargonium sidoides syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-0165
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

Inactive Ingredients
Ingredient Name	Strength
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
FRUCTOSE (UNII: 6YSS42VSEV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (NATURAL CHERRY FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-0165-5	1 in 1 CARTON	09/01/2009
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2009

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc		831153908	manufacture(53499-0165)