UMCKA MENTHOL- pelargonium sidoides syrup

Umcka Menthol by

Drug Labeling and Warnings

Umcka Menthol 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: ETHYLALCOHOL (8.2%), FRUCTOSE, GLYCERIN, MALTODEXTRIN, MENTHOL, NATURAL FLAVOR, PURIFIED WATER.

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.

Adults and children 12 years of age and older: take 1 1/2 teaspoon (tsp) (7.5 mL) 3 times daily.

Children under 12 years of age: consult a physician.

Indications and Usage:

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

Purpose:

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

WARNINGS

Warning:

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.

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 the 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.

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).

Pregnancy or Breast Feeding:

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.

UMCKA ColdCare Mint-Menthol Syrup

INGREDIENTS AND APPEARANCE

UMCKA MENTHOL 
pelargonium sidoides syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5272
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
ALCOHOL (UNII: 3K9958V90M)
FRUCTOSE (UNII: 6YSS42VSEV)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5272-5	1 in 1 CARTON	01/01/2006
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 53499-5272-9	1 in 1 CARTON	01/01/2006
2		240 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		01/01/2006

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc		831153908	manufacture(53499-5272)