FDA Label for Umcka Original Coldcare

View Indications, Usage & Precautions

Umcka Original Coldcare Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America. 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:

Ethyl Alcohol 13%

Glycerin

Maltodextrin

Purified Water.


Dosage & 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. 

Adults and children 12 years of age and older: take 1.5 mL 3 times daily by mouth.

Children under 12 years of age: consult a physician.


Indications & Usage



Indications and Usage:

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


Otc - Purpose



Purpose:

Shortens duration and reduces severity of symptoms associated with common cold and throat/nasal/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 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, a cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 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 the reach of children.


Otc - Ask Doctor



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, a cough accompanied by excessive phlegm (mucus).


Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 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 Breastfeeding:

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


Overdosage



Overdosage:

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


Nature's Way Umcka Cold Care Original Drops15790 2 Oz15270 1 Oz



15270_UMCKA_ORIGINAL CC_A01


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