Otc - Active Ingredient
Active Ingredient:
PELARGONIUM SIDOIDES 1X
ACONITUM NAPELLUS 4X
BRYONIA 4X
EUCALYPTUS GLOBULUS 2X
EUPATORIUM PERFOLIATUM 6X
GELSEMIUM SEMPERVIRENS 4X
IPECACUANHA 3X
PHOSPHORUS 6X
Umcka Cold Flu Orange
FDA Label NDC 53499-9161
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 Amertica, Inc. for the product Umcka Cold Flu Orange (NDC 53499-9161). 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 - keep out of reach of children, 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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALIC ACID
MANNITOL
MALTODEXTRIN
NATURAL ORANGE FLAVORS
STEARIC ACID
SORBITOL
XYLITOL
Dosage & Administration
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 4-5 times daily.
Children 6-11 years of age: take 1 chewable tablet 2-4 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, and temporarily relieves flu symptoms: chills/fever, congestion/stuff nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, sore throat.
Otc - Purpose
Purpose:
Shortens duration and reduces severity of symptoms associated with the common cold and throat/sinus/bronchial infections, and temporarily relieves flu symptoms: chills/fever, congestion/stuff nose, cough, headache, hoarseness, minor aches/pains, sneezing/runny nose, 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, vimiting 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 a cough accompanied by excessive phlegm (mucus).
Stop use and ask a doctor 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: persistent or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema or is a cough accompanied by excessive phlegm (mucus).
Stop use and ask a doctor 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 - Keep Out Of Reach Of Children
Keep out of Reach of Children:
Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding
Pregnancy or Breast Feeding:
If pregnant or breast-feeding, ask a healthcare professional before use.
Package Label.Principal Display Panel
Packaging Label. Principal Display Panel:
15161 Umcka Cold + Flu Orange Chewable Tablets (20 tabs)
UMCKA 15161_COLD+FLU_ORANGE_CHEW_A01
* Please review the disclaimer below.
