FDA Label for Umcka Coldcare Starter Kit

View Indications, Usage & Precautions

Umcka Coldcare Starter Kit 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 Ingredients:



Cherry Syrup  Pelargonium sidoides 1X

Lemon Packet: Pelargonium sidoides 1X


Inactive Ingredients:



Cherry Syrup:  Aronia Juice, Citric Acid, Ethyl Alcohol (0.05%), Fructose, Maltodextrin, Natural Cherry Flavor, Potassium Citrate, Purified Water

Lemon Powder: Citric Acid, Maltodextrin, Silicon Dioxide, Turmeric, Xylitol


Indications And Usage



Cherry Syrup:  Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, hoarseness, sore throat.

Lemon Powder:  Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, headache, hoarseness, sore throat.


Otc - Purpose



Cherry Syrup: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, hoarseness, sore throat.


Lemon Powder: Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irriations: congestion, cough, headache, hoarseness, sore throat.


Warnings



Cherry Syrup:  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.

Lemon Powder: 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.


Otc  Ask The Doctor



Cherry Sysrup: Ask the 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).

Lemon Powder:  Ask the 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



Cherry Syrup:  Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within seven days, fever worsens or lasts more than three days, cough lasts more than seven days or occurs with rash or persistent headache.

These could be signs of a serious condition.

Lemon Powder:  Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within seven days, fever worsens or lasts more than three days, cough lasts more than seven days or occurs with rash or persistent headache.

These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



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

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


Otc - Keep Out Of Reach Of Children



Cherry Syrup:  Keep out of reach of children

Lemon Powder:  Keep out of reach of children


Overdose



Cherry Syrup:  In case of overdose, seek medical help or contact a Poison Control Center immediately

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


Dosage & Administration



Cherry Syrup:  For best results, use at first sign of symptoms and continue to use for an adaditional 48 hours after symptoms cease. 

Use only with enclosed dosage cup.

Adults and children 12 years of age and older:  take 1 1/2 teaspomm (7.5 mL) three times daily

Chidlren 6 - 11 years of age:  take 1 teaspoon (5 mL) three times daily

Children under 6 years of age:  Consult a physician

Lemon Powder:  For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symtoms cease.

Dissolve contents of 1 packet in 4-6 ounces of hot water and sip while hot.

May also be dissolved in 4-6 ounces of cold water, which may be preferable for children.

Adults and chilrden 12 years of age and older:  take 3-4 times daily

Children 6-11 years of age:  take 2-3 times daily

Children under 6 years of age:  consult a doctor


15273 Umcka Coldcare Cherry Syrup 4 Oz



15273_A04_UMCKACOLD_Cherry Syrup


15146 Umcka Coldcare Lemon Hot Drink Powder



15146_04_UMCKACOLD_LEMON 10 packets


12137 Umcka Coldcare Starter Kit



12137_Umcka_Starter Kit_10


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