Active Ingredient
(in each tablet)
Levocetirizine dihydrochloride 5 mg
Xyzal Allergy 24hr Tablet
FDA Label NDC 41167-3513
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Xyzal Allergy 24hr (NDC 41167-3513). 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, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
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
Ask A Doctor Before Use If You Have
- ever had trouble urinating or emptying your bladder
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 If
- you have trouble urinating or emptying your bladder
- an 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 65 years of age and older | ■ ask a doctor |
| adults and children 12-64 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 6-11 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 |
(Note: Age ranges are bolded in the draft container labeling for tablet bottle)
Other Information
- store between 20° and 25°C (68° and 77°F)
- (if blister) safety sealed: do not use if carton was opened or if individual blister unit is open or torn
(if bottled) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
(if stretch card) safety sealed: do not use if sealed package was torn or opened, or if printed foil inner seal on bottle is torn or missing
Inactive Ingredients
Colloidal anhydrous silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide
Questions Or Comments?
call 1-800-633-1610
Principal Display Panel
NDC 41167-3510-0
XYZAL
Allergy 24HR
5 mg
10 Tablets
Principal Display Panelndc 41167-3510-0xyzalallergy 24hr5 mg10 Tablets (Xyzal Allergy 24hr 01)
NDC 41167-3510-1
XYZAL
Allergy 24HR
5 mg
35 Tablets
Principal Display Panelndc 41167-3510-1xyzalallergy 24hr5 mg35 Tablets (Xyzal Allergy 24hr 02)
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