Active Ingredient Section
Pelargonium sidoides 1X,
Hydrastis canadensis 6X,
Kali muriaticum 3X (Potassium chloride),
Sanguinaria canadensis 6X,
Pulsatilla 6X,
Silicea 6X (Silicon Dioxide)
Umcka Allergy And Sinus Tablet, Chewable
FDA Label NDC 53499-3194
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 American, Inc. for the product Umcka Allergy And Sinus (NDC 53499-3194). 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 active ingredient section, inactive ingredient section, purpose section, indications and usage section, warnings section, ask a doctor section, stop use section, pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient Section
sour Cherry Powder,
Citric Acid,
Lactose monohydrate,
Magnesium Sterate,
Malic Acid,
Maltodextrin,
Mannitol,
Natural Flavors,
Croscarmellose Sodium,
Sorbitol,
Stearic acid,
Xylitol
Purpose Section
Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.
Indications And Usage Section
Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations and temporarily relieves allergy and sinus symptoms; cough, congestion, promotes sinus drainage, helps decongest sinus openings and passages, headache, sneezing/runny nose, burning, itchy eyes, sore throat, shrinks swollen nasal membranes, sinus presssure.
Warnings Section
Sore throat warning: severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting or rash maybe serious.
Consult a physician promptly.
Ask A Doctor Section
Ask a doctor before use if you have a persistant or chronic cough that lasts, is chronic such as ocurs with smoking, asthma, chronic bronchitis, or emphysema or is accompanied by excessive phlegm (mucus).
Stop Use Section
Stop use and ask a doctor is 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.
Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep Out Of Reach Of Children Section
Keep out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center immediatley.
Dosage And Administration Section
Chew or dissolve tablets in the mouth.
Do not swallow whole.
For best resutls, use at the 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.
* Please review the disclaimer below.
