Otc - Active Ingredient
Active Ingredient:
PELARGONIUM SIDOIDES 1x
Umcka Coldcare Alcohol-free Liquid
FDA Label NDC 53499-5271
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 Coldcare Alcohol-free (NDC 53499-5271). 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: Citric acid, ethyl alcohol, glycerin, maltodextrin, potassium sorbate, purified water, sorbitol.
Dosage & 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 1.5 mL 3 times daily by mouth.
Children 6-11 years of age: take 1 mL 3 times daily by mouth.
Children under 6 years of age: consult a doctor.
Indications & Usage
Uses: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.
Otc - Purpose
OTC Purpose: Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: congestion, cough, headache, hoarseness, sore throat.
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 serions.
Consult a physician promptly.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Otc - Ask Doctor
OTC ASK DOCTOR:
Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
A cough accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days.
Cough lasts more than 7 days or occurs with rash or persistent headache.
Fever worsens or lasts more than 3 days.
These could be signs of a serious condition.
Overdosage
OVERDOSE WARNING:
In case of overdose, seek medical help or contact a Poison Control Center immediately.
Otc - Pregnancy Or Breast Feeding
OTC Pregnancy or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Package Label.Principal Display Panel
Umcka ColdCare 99.9% Alcohol Free Liquid
15271 1 oz
15791 2 oz
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