FDA Label for Umcka Coldcare Childrens Cherry

View Indications, Usage & Precautions

Umcka Coldcare Childrens 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:

ARONIA  JUICE

CITRIC ACID

ALCOHOL (0.05%)

FRUCTOSE

MALTODEXTRIN

NATURAL CHERRY FLAVOR

POTASSIUM CITRATE

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.

Children 12 years of age and older: Take 1.5 teaspoons (7.5mL) three times daily.
Children 6-11 years of age: Take 1 teaspoon (5mL) three times daily.
Children under 6 years of age: Ask a doctor.


Indications & Usage



Indications and Usage:

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


Otc - Purpose



Purpose:

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


Warnings



Warnings:  Sore throat warning: Severe or persistent sore throat for more than 2 days of if accompanied by high fever, headache, nausea, vomiting or rash may be serious.

Consult a physician promptly.

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

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better in 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.


Otc - Keep Out Of Reach Of Children



Keep Out of Reach of Children:

Keep out of the reach of children.


Otc - Ask Doctor



Ask the Doctor:

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

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better in 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.


Otc - Pregnancy Or Breast Feeding



Pregnancy or Breast Feeding:

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


Overdosage



Overdosage:

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


Package Label.Principal Display Panel



60165_UMCKA COLDCARE CHILDRENS CHERRY_A02  4 Fluid Oz.


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