Otc - Active Ingredient
Active Ingredient: PELARGONIUM SIDOIDES 1X.
Umcka Menthol Syrup
FDA Label NDC 53499-5272
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc for the product Umcka Menthol (NDC 53499-5272). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, dosage & administration, indications & usage, otc - purpose, warnings, otc - keep out of reach of children, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients: ALCOHOL (8.2%), FRUCTOSE, NATURAL MENTHOL, NATURAL SPEARMINT FLAVOR, PURIFIED WATER, VEGETABLE-SOURCE GLYCERIN, MALTODEXTRIN.
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.
Adults and children 12 years of age and older: take 1 1/2 teaspoon (7.5 mL) 3 times daily.
Children under 12 years of age: consult a doctor.
Indications & Usage
Indications and Usage:
Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.
Otc - Purpose
Purpose:
Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.
Warnings
Warning:
Sore throat warning: Severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, rash, nausea or vomiting may be serious.
Consult a physician promptly.
Stop use and ask the 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).
Otc - Pregnancy Or Breast Feeding
Pregnancy or Breast Feeding:
If pregnant or breast-feeding, ask a healthcare professional before use.
Overdosage
Overdosage section:
In case of overdose, seek medical help or contact a Poison Control Center immediately.
Umcka Coldcare Mint-Menthol Syrup
UMCKA ColdCare Mint-Menthol Syrup
15272 4 oz
15972 8 oz.
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