Goodmeds Non Drowsy Allergy Relief Tablet
FDA Label NDC 82725-4202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cabinet Health P.b.c. for the product Goodmeds Non Drowsy Allergy Relief (NDC 82725-4202). 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), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, 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)
Fexofenadine HCl USP, 180 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat
Warnings
Do Not Use
if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
kidney disease. Your doctor should determine if you need a different dose.
When Using This Product
do not take more than directed • do not take at the same time as aluminum or magnesium antacids • do not take with fruit juices (see Directions)
Stop Use And Ask A Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding,
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 12 years of age and over | take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours |
| children under 12 years of age | do not use |
| adults 65 years of age and older | ask a doctor |
| consumers with kidney disease | ask a doctor |
Other Information
• safety sealed: do not use if imprinted foil under bottle cap is opened or torn • store between 20° and 25°C (68° and 77°F) • protect from excessive moisture
Inactive Ingredients
colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide
Questions Or Comments?
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