Allergy Relief Tablet, Film Coated
FDA Label NDC 70677-1241
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Allergy Relief (NDC 70677-1241). 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 drug facts, active ingredient (in each tablet) cetirizine hcl 10 mg, purpose antihistamine, uses● temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ● runny nose ● sneezing ● itchy, watery eyes ● itching of the nose or throat, warnings, ask a doctor before use if you haveliver or kidney disease. your doctor should determine if you need a different dose., ask a doctor or pharmacist before use if you aretaking tranquilizers or sedatives., when using this product ● drowsiness may occur ● avoid alcoholic drinks ● alcohol, sedatives, and tranquilizers may increase drowsiness ● be careful when driving a motor vehicle or operating machinery, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet) Cetirizine Hcl 10 Mg
Purpose Antihistamine
Uses● Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies: ● Runny Nose ● Sneezing ● Itchy, Watery Eyes ● Itching Of The Nose Or Throat
Warnings
Do not useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask A Doctor Before Use If You Haveliver Or Kidney Disease. Your Doctor Should Determine If You Need A Different Dose.
Ask A Doctor Or Pharmacist Before Use If You Aretaking Tranquilizers Or Sedatives.
When Using This Product ● Drowsiness May Occur ● Avoid Alcoholic Drinks ● Alcohol, Sedatives, And Tranquilizers May Increase Drowsiness ● Be Careful When Driving A Motor Vehicle Or Operating Machinery
Stop Use And Ask A Doctor Ifan Allergic Reaction To This Product Occurs. Seek Medical Help Right Away.
If Pregnant Or Breast-Feeding: ● If Breast-Feeding: Not Recommended ● If Pregnant: Ask A Health Professional Before Use.
Keep Out Of Reach Of Children.In Case Of Overdose, Get Medical Help Or Contact A Poison Control Center Right Away. (1-800-222-1222)
Directions ● Adults And Children 6 Years And Over: One 10 Mg Tablet Once Daily; Do Not Take More Than One 10 Mg Tablet In 24 Hours. A 5 Mg Product May Be Appropriate For Less Severe Symptoms ● Adults 65 Years And Over : Ask A Doctor ● Children Under 6 Years Of Age : Ask A Doctor ● Consumers With Liver Or Kidney Disease : Ask A Doctor
Other Information Store Between 20° To 25°C (68° To 77°F)
Inactive Ingredients Colloidal Silicon Dioxide**, Croscarmellose Sodium**, Hypromellose, Lactose, Magnesium Stearate, Maize Starch**, Microcrystalline Cellulose**, Polyethylene Glycol, Povidone**, Titanium Dioxide **Containes One Or More Of These Ingrdients
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