UMCKA COLDCARE MINT CHEWABLE- pelargonium sidoides tablet, chewable

Umcka ColdCare Mint Chewable by

Drug Labeling and Warnings

Umcka ColdCare Mint Chewable 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]

ACTIVE INGREDIENT

Active Ingredient:

PELARGONIUM SIDOIDES  1X

Inactive Ingredients:

ETHYL ALCOHOL (0.3%)

MAGNESIUM STEARATE

MALTODEXTRIN

MANNITOL

SODIUM CROSCARMELLOSE

NATURAL MENTHOL FLAVOR

NATURAL SPEARMINT FLAVOR

SORBITOL

STEARIC ACID

XYLITOL

DOSAGE & ADMINISTRATION

Dosage and Administration:

Nature's Way Brand:

Directions:

Chew or dissolve tablets in the mouth.

Do not swallow whole.

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 chewable tablet 3 times daily.
Children 6-11 years of age: take 1 chewable tablet 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 infections: congestion, cough, hoarseness, sore throat.

Purpose:

Shortens duration and reduces severity of upper respiratory symptoms.

WARNINGS

Warnings:

Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied by by high fever, headache, nausea, vomiting or rash may be serious.

Consulta physician promptly.

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.

Keep out of Reach of Children:

Keep out of reach of children.

Ask the 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UMCKA COLDCARE MINT CHEWABLE 
pelargonium sidoides tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-9145
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]

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MENTHOL (UNII: L7T10EIP3A)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
XYLITOL (UNII: VCQ006KQ1E)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	white (WHITE TABLET)	Score	no score
Shape	ROUND (C)	Size	16mm
Flavor	MENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR)	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-9145-0	2 in 1 CARTON	12/29/2016
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/29/2016

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-9145)