UMCKA THROAT- pelargonium sidoides root spray

UMCKA THROAT by

Drug Labeling and Warnings

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

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Pelargonium Sidoides Root 1X

INACTIVE INGREDIENT SECTION

Xylitol 

Maltodextrin

Menthol

Lquid Spearmint Flavor

Liquid Cherry Flavor

Glycerin

Ethyl Alcohol  8.5%

Purified Water

OTC - PURPOSE SECTION

Shortens duration and reduces severity of symptons associated with a sore throat.

INDICATIONS & USAGE SECTION

Shortens duration and reduces severity of symptons associated with a sore throat.

DOSAGE & ADMINISTRATION SECTION

Directions:

Shake well before use.

For best results, use at first sign of symptoms.

Continue use for an additional 48 hours after symptoms cease.

Adults & children 12 years of age and older: apply 4 sprays into the back of the mouth 3 times daily.

Children under 12 years of age: Ask a physician.

WARNINGS SECTION

Sore Throat warning: severe or persistent more than 2 days, or if accompanied by a high fever, headache, nausea, vomiting, or rash consult a doctor promptly.

Ask a doctor before use if you have a presistent or chronic cough that lasts, is chronic such as occurs with smoking, astham, chronic bronchitis, or emphysema, or is accompanied by excessive phelgm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms get worse, lasts more than 7 days or fever worsens or lasts more than 3 days.

These could be signs of a serious condition.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a presistent or chronic cough that lasts, is chronic such as occurs with smoking, astham, chronic bronchitis, or emphysema, or is accompanied by excessive phelgm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms get worse, lasts more than 7 days or fever worsens or lasts more than 3 days.

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OVERDOSAGE SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UMCKA THROAT 
pelargonium sidoides root spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-0533
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 59 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
MENTHOL (UNII: L7T10EIP3A)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
SPEARMINT (UNII: J7I2T6IV1N)
CHERRY JUICE (UNII: 4XTQ10247Y)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT, CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-0533-2	1 in 1 BOX	09/01/2014
1		59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2014

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-0533)