Otc - Active Ingredient
Active Ingredient:
PELARGONIUM SIDOIDES 1X
Umcka Fastactives Cherry
FDA Label NDC 53499-1166
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 Fastactives Cherry (NDC 53499-1166). 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 - ask doctor, otc - pregnancy or breast feeding, 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, MALIC ACID, MALTODEXTRIN, NATURAL FLAVOR, SILICA, XYLITOL.
Dosage & Administration
Dosage and Administration:
Nature's Way Brand:
Directions:
Tear packet open, pour contents into mouth and swallow.
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 contents of 1 packet 3 times daily.
Children 6-11 years of age: take contents of 1 packet 2 times daily.
Children under 6 years of age: consult a physician.
Indications & Usage
Indications and Usage:
Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections: congestion, cough, hoarseness, sore throat.
Otc - Purpose
Purpose:
Shortens duration and reduces severity of upper respiratory symptoms.
Warnings
Warnings:
Sore throat warning: Severe or persistent sore throat for more than 2 days of if accompanied by high fever, headache, nausea, vomiting or rash may be serious.
Consult a physician pomptly.
Ask a doctor before use if you have a cough that lasts, is chronic such as occurs with smoking, asthma or emphysema, or is accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 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 - Ask Doctor
Ask the Doctor:
Ask a doctor before use if you have a cough that lasts, is chronic such as occurs with smoking, asthma, or emphysema, or is accompanied by excessive phlegm (mucus).
Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 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
Pregnancy or Breast Feeding:
If pregnant or breast-feeding, ask a healthcare professional before use.
Umcka Fast Actives Cherry Flavored (60166)
Packaging Label. Principal Display Panel:
Umcka 60166 CC Fastactives Cherry.jpg
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