UMCKA COLDCARE CHERRY- pelargonium sidoides tablet, chewable

Umcka Coldcare Cherry by

Drug Labeling and Warnings

Umcka Coldcare Cherry 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:

CITRIC ACID

ETHYL ALCOHOL (0.3%)

MAGNESIUM STEARATE

MALIC ACID

MALTODEXTRIN

MANNITOL

SODIUM CROSCARMELLOSE

NATURAL 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/bronchial infections: congestion, cough, hoarseness, sore throat.

Purpose:

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

WARNINGS

Warnings: Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor 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 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 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 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 CHERRY 
pelargonium sidoides tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5144
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALIC ACID (UNII: 817L1N4CKP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	pink (CHERRY TABLET)	Score	no score
Shape	ROUND (C)	Size	16mm
Flavor	CHERRY (NATURAL CHERRY FLAVOR)	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5144-0	2 in 1 CARTON	08/24/2011
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		08/24/2011

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-5144)