Active Ingredient
Pelargonium sidoides 1X
Hydrastis canadensis 6X
Kali muriaticum 3X
Sanguinaria canadensis 6X
Pulsatilla 6X
Silicea 6X
Allergy And Sinus Relief Tablet, Chewable
FDA Label NDC 53499-4194
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 Allergy And Sinus Relief (NDC 53499-4194). 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, inactive ingredient, purpose, indications & usage, dosage & administration, warnings, ask doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Citric Acid
Lactose Monohydrate
Magnesium Stearate
Malic Acid
Maltodextrin
Mannitol
Natural Flavor
Sodium Croscarmellose
Sorbitol
Sour Cherry Powder
Stearic acid
Xylitol
Purpose
Temporarily relieves allergy and sinus symptoms.
Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations: cough, headache, hoarseness, sore throat, sinus pressure, chest congestion, nasal congestion, sneezing/runny nose, shrinks swollen nasal membranes, promotes sinus drainage, burning, itchy eyes, helps decongest sinus openings and passages.
Indications & Usage
Temporarily relieves allergy and sinus symptoms.
Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations: cough, headache, hoarseness, sore throat, sinus pressure, chest congestion, nasal congestion, sneezing/runny nose, shrinks swollen nasal membranes, promotes sinus drainage, burning, itchy eyes, helps decongest sinus openings and passages.
Dosage & Administration
Directions
Chew or dissolve tablets in the mouth. Do not swallow whole. For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.
Adults & Children 13 years of age and older: Take 1 chewable tablet three times daily.
Children 6-12 of age: Take 1 chewable tablet two times daily.
Children under 6 years of age: Consult a doctor.
Warnings
Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family
Stop Use
Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 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
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose
In case of overdose, seek medical help or contact a Poison Control center right away.
* Please review the disclaimer below.
