FDA Label for Umcka Cold Flu Berry Chewable

View Indications, Usage & Precautions

Umcka Cold Flu Berry Chewable 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.

Umcka Cold+ Flu Chewable Berry Tablets



Active Ingredient:

PELARGONIUM SIDOIDES 1X

ACONITUM NAPELLUS 4X

BRYONIA 4X

EUCALYPTUS GLOBULUS 2X

EUPATORIUM PERFOLIATUM 6X

GELSEMIUM SEMPERVIRENS 4X

IPECACUANHA 3X

PHOSPHORUS 6X


Inactive Ingredient



Inactive Ingredients:

ANNATTO

BEET JUICE

LACTOSE MONOHYDRATE

CARAMEL COLOR

MAGNESIUM STEARATE

MALIC ACID

MALTODEXTRIN

MANNiTOL

SODIUM CROSCARMELLOSE

NATURAL BERRY 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, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat.  


Otc - Purpose



Purpose:

Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms: chills/fever, congestion/stuffy nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat.  


Warnings



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

Consult a physician promptly.

Ask a doctor before use if you have: 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 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 reach of children.


Otc - Ask Doctor



Ask the Doctor:

Ask a doctor before use if you have: 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 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 Breast Feeding:

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


Umcka Cold + Flu Chewable Tablets15159  20 Tablets



15159_A01_UMCKA Berry Cold plus Flu 20 Chewable tablets


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