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  5. Label Information: Umcka Cough Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root

FDA Label for Umcka Cough Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. INDICATIONS & USAGE
    4. DOSAGE & ADMINISTRATION
    5. WARNINGS
    6. OVERDOSAGE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. OTC - PURPOSE
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Umcka Cough Aconitum Napellus, Bryonia Alba Root, Calcium Sulfide, Spongia Officinalis Skeleton, Roasted , Tin, Pelargonium Sidoides Root 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 Ingredients:

Pelargonium sidoides 1X

Aconitum napellus 3X

Bryonia 3X 

Hepar sulphuris calcareum 6C

Stannum metallicum 6C

Spongia tosta 3X


Inactive Ingredient



Inactive Ingredients:

Citric acid

English ivy leaf extract

Ethyl Alcohol (0.05%)

Vegetable-source glycerin

Lactose Monohydrate

Maltodextrin

Purified water

Sorbitol


Indications & Usage



Uses:

Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat, sneezing, stuffy/runny nose. 

Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.


Dosage & Administration



Directions:

For best results, use at first sign of symptoms.

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 teaspoons (7.5 mL) three times daily.

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

Children under 6 years of age: Consult a physician.


Warnings



Warnings 

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:  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 get worse or last more than 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 a sign of a serious condition.


Overdosage



Overdose:

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


Otc - Pregnancy Or Breast Feeding



Pregnancy or Breast Feeding:

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


Otc - Keep Out Of Reach Of Children



Keep out of Reach of Children:

Keep out of reach of children.  


Otc - Purpose



Purpose:

Shortens duration and reduces severity of symptoms associated with common colds and throat/nasal/bronchial irritations: congestion, cough, hoarseness, sore throat, sneezing, stuffy/runny nose.
Temporarily relieves cough due to minor bronchial and throat irritations as may occur with a cold.


Package Label.Principal Display Panel



UMCKA 15864 Cough Max Relief 4 oz


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