Allergy Relief Tablet, Coated
FDA Label NDC 76162-915
16 label sections · Submitted to the FDA by Topco Associates, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Allergy Relief (NDC 76162-915). 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, use, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, 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)
Levocetirizine dihydrochloride USP 5 mg
Purpose
Antihistamine
Use
temporarily relieves these symptoms due to hay fever or other respiratory allergies:
• runny nose • sneezing • itchy, watery eyes
• itching of the nose or throat
Otc - Do Not Use
Do not use
• if you have
kidney disease
• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine
Otc - Ask Doctor
Ask a doctor before use if you have
• ever had trouble urinating or emptying your bladder
Otc - When Using
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
Otc - Stop Use
Stop use and ask a doctor if
• you have trouble urinating or emptying your bladder
• an allergic reaction to this product occurs.
Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding
• if breast-feeding: not recommended
• if pregnant: ask a health professional before use
Otc - Keep Out Of Reach Of Children
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 65 years of age and older | • ask a doctor |
| adults and children 12 to 64 years of age | • take 1 tablet (5 mg) once daily in the evening
• do not take more than 1 tablet (5 mg) in 24 hours • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms |
| children 6 to 11 years of age | • take ½ tablet (2.5 mg) once daily in the evening
• do not take more than ½ tablet (2.5 mg) in 24 hours |
| children under 6 years of age | • do not use |
| consumers with kidney disease | • do not use |
Other Information
• store between 20° and 25°C (68° and 77°F)
• safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
Inactive Ingredients
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.
Questions Or Comments?
call 1-800-373-6981
Other
Distributed by:
TOPCO ASSOCIATES LLC
Itasca, IL 60143
Principal Display Panel
Allergy Relief
Levocetirizine Dihydrochloride Tablets USP, 5 mg
Carton 35 Ct.
Label 35 ct.
Carton 80 Ct.
Label 80 Ct.
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