Active Ingredient(S)
Levocetirizine dihydrochloride USP 5 mg
Allery Relief 24hr Tablet, Film Coated
FDA Label NDC 69168-451
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Allery Relief 24hr (NDC 69168-451). 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(s), purpose, use(s), do not use, ask a doctor before use if, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Use(S)
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
- 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 Breastfeeding,
- 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 |
|
| adults and children 12 to 64 years of age |
|
| children 6 to 11 years of age |
|
| children under 6 years of age |
|
| consumers with kidney disease |
|
Other Information
- store at room temperature 20°– 25°C (68°– 77°F)
- do not use if imprinted seal under safety cap is broken or missing
Inactive Ingredients
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
Questions/Comments
Call 1-888-952-0050 Monday through Friday 9AM - 5PM
Principal Display Panel
Allergy Relief 24HR
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