UMCKA COLDCARE LEMON- pelargonium sidoides powder

Umcka Coldcare Lemon by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

PELARGONIUM SIDOIDES 1X

Inactive Ingredients: citric acid, maltodextrin, natural flavor, silica, turmeric color, xylitol.

DOSAGE & ADMINISTRATION

Dosage and Administration:

Nature's Way Brand:

Directions:

Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.

May also be dissolved in 4-6 ounces of cold water, which may be preferable for children.

For best results, use at the 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 3 times daily.

Children 6-11 years of age: take 2 times daily.

Children under 6 years of age: consult a physician.

Indications and Usage:

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

Purpose:

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

WARNINGS

Warnings

Sore throat warning: Severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting or rash may be serious.

Consult a physician promptly.

Keep out of Reach of Children:

Keep out of reach of children.

Ask a Doctor:

Ask a doctor before use if you have a persistent or chronic cough thats 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 signs of a serious condition.

Pregnancy or Breast Feeding:

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

Overdosage:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UMCKA COLDCARE LEMON  
pelargonium sidoides powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5146
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 5 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TURMERIC (UNII: 856YO1Z64F)
XYLITOL (UNII: VCQ006KQ1E)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5146-0	10 in 1 CARTON	07/01/2009
1		5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2009

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-5146)