FDA Label for Umcka Coldcare Cherry

View Indications, Usage & Precautions

Umcka Coldcare Cherry Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient:

PELARGONIUM SIDOIDES 1X


Inactive Ingredient



Inactive Ingredients:

CITRIC ACID

MAGNESIUM STEARATE

MALIC ACID

MALTODEXTRIN

MANNITOL

MODIFIED CELLULOSE GUM

NATURAL CHERRY 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 4-5 times daily.
Children 6-11 years of age: take 1 chewable tablet 2-4 times daily.
Children under 6 years of age: consult a doctor.


Indications & Usage



Indications and Usage:

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


Otc - Purpose



Purpose:

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations:  congestion, cough, headache, 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: persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, 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:

Keep out of reach of children.


Otc - Ask Doctor



Ask the Doctor:

Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma or emphysema, a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days.

These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



Pregnancy or Breast Feeding:

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


Package Label.Principal Display Panel



Packaging Label. Principal Display Panel:

15144 UMCKA CC Cherry Chewable  20 tablets


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