UMCKA COLDCARE ALCOHOL FREE CHERRY- pelargonium sidoides syrup

Umcka ColdCare Alcohol Free Cherry by

Drug Labeling and Warnings

Umcka ColdCare Alcohol Free 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

ETHYL 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. 

Adults and children 12 years of age and older: take 1 1/2 teaspoon (7.5mL) 3 times daily.
Children 6-11 years of age: take 1 teaspoon (5mL) 3 times daily.
Children under 6 years of age: consult a physician.

Indications and Usage Section:

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

Purpose:

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

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.

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 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, or cough lasts more than 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.

Overdose:

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

Package Label. Principal Display Panel:15793 Umcka ColdCare Cherry Alcohol Free 8 pz 15273 Umcka ColdCare Cherry Alcohol Free 4 oz15301 Umcka ColdCare Cherry Alcohol Free 10 ml Sample size 

INGREDIENTS AND APPEARANCE

UMCKA COLDCARE ALCOHOL FREE CHERRY 
pelargonium sidoides syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5273
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 240 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: 53499-5273-5	1 in 1 CARTON	01/01/2006
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 53499-5273-9	1 in 1 CARTON	01/01/2006
2		240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 53499-5273-7	10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2006

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc		831153908	manufacture(53499-5273)