UMCKA COLDCARE ALCOHOL-FREE- pelargonium sidoides liquid

Umcka ColdCare Alcohol-Free by

Drug Labeling and Warnings

Umcka ColdCare Alcohol-Free 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:  Citric acid, ethyl alcohol, glycerin, maltodextrin, potassium sorbate, purified water, sorbitol.

DOSAGE & 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 1.5 mL 3 times daily by mouth.

Children 6-11 years of age: take 1 mL 3 times daily by mouth.

Children under 6 years of age: consult a physician.

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

OTC 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 or if accompanied by high fever, headache, nausea, vomiting or rash may be serions.

Consult a physician promptly.

Keep out of the reach of children.

ASK 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 get worsen or do not get better within 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.

OVERDOSE WARNING:

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

OTC  Pregnancy or Breast Feeding

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UMCKA COLDCARE ALCOHOL-FREE 
pelargonium sidoides liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5271
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 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5271-4	1 in 1 CARTON	02/02/2009
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 53499-5271-8	1 in 1 CARTON	02/02/2009
2		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/02/2009

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-5271)