Umcka coldcare mint chewable tablet, chewable

Otc - active ingredient section

Active Ingredient:

PELARGONIUM SIDOIDES 1X

Inactive ingredient section

Inactive Ingredients:

ETHYL ALCOHOL (0.3%)

MAGNESIUM STEARATE

MALTODEXTRIN

MANNITOL

SODIUM CROSCARMELLOSE


NATURAL MENTHOL FLAVOR

NATURAL SPEARMINT FLAVOR

SORBITOL

STEARIC ACID

XYLITOL

Dosage & administration section

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 3 times daily.
Children 6-11 years of age: take 1 chewable tablet 2 times daily.
Children under 6 years of age:consult a physician.

Indications & usage section

Indications and Usage:

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

Otc - purpose section

Purpose:

Shortens duration and reduces severity of upper respiratory symptoms.

Warnings section

Warnings:

Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied by by high fever, headache, nausea, vomiting or rash may be serious.

Consulta physician promptly.


Ask a doctor before use if you have a persistent or chronic cough thats 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 signs of a serious condition.

Otc - keep out of reach of children section

Keep out of Reach of Children:

Keep out of reach of children.

Otc - ask doctor section

Ask the Doctor:

Ask a doctor before use if you have a persistent or chronic cough thats 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 signs of a serious condition.

Otc - pregnancy or breast feeding section

Pregnancy or Breast Feeding:

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

Ingredients and appearance - Product information

Umcka coldcare mint chewable tablet, chewable- Pelargonium sidoides

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 53499-9145
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Pelargonium sidoides root ( UNII: H6J53HEX8E)( Pelargonium sidoides root - UNII: H6J53HEX8E ) 1 [hp_X]in 1

Inactive Ingredients

Ingredient Name Code
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Mannitol ( UNII: 3OWL53L36A)
Croscarmellose sodium ( UNII: M28OL1HH48)
Menthol ( UNII: L7T10EIP3A)
Sorbitol ( UNII: 506T60A25R)
Stearic acid ( UNII: 4ELV7Z65AP)
Xylitol ( UNII: VCQ006KQ1E)
Alcohol ( UNII: 3K9958V90M)

Product Characteristics

Flavor SPEARMINT (NATURAL SPEARMINT FLAVOR) Color white (WHITE TABLET)
Score 1 Shape ROUND (C)
Imprint Code C Size 16 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved homeopathic USA

Labeler - Schwabe North America, Inc( 831153908)

Establishment

Name ID/FEI Business Operations
Schwabe North America, Inc 831153908 manufacture( 53499-9145)

Package label.principal display panel