FDA Label for Umcka Cold Flu Berry

View Indications, Usage & Precautions

Umcka Cold Flu Berry 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 Ingredients: PELARGONIUM SIDOIDES 1XACONITUM NAPELLUS 4X, BRYONIA 4X, EUCALYPTUS GLOBULUS 2X, EUPATORIUM PERFOLIATUM 6X, GELSEMIUM SEMPERVIRENS 4X, PHOSPHORUS 6X, IPECACUANHA 3X,


Inactive Ingredient



Inactive Ingredients:   Aronia juice, citiric acid, ethyl alcohol (0.05%), glycerin, lactose monohydrate, maltodextrin, natural flavors, purified water, sorbitol.


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.

Adults and children 12 years of age and older: take 1 1/2 teaspoon (7.5 mL) 3 times daily.

Children 6 to 11 years of age: take 1 teaspoon (5 mL) 3 times daily.

Children under 6 years of age: consult a physician.


Otc - Purpose



OTC Purpose: 

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


Indications & Usage



Indications and Usage:

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


Warnings



Warning:

Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied or followed by a fever, headache, rash, nausea or vomiting 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, 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, fever worsens or lasts more than 3 days, or 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 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 worsen or do not get better within 7 days, fever worsens or lasts more than 3 days, or 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. 


Umcka Cold + Flu Fructose Free Berry Flavored Syrup (15148)  4 Oz



Package Label Principal Display:

15148_UMCKA CF Berry_A01


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