Otc - Active Ingredient
Active ingredient (in each caplet)
Levocetirizine HCl 5 mg
Goodmeds Levocetirizine Dihydrochloride 5mg 365 Count Tablet
FDA Label NDC 82725-4051
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 Levocetirizine Dihydrochloride 5mg 365 Count (NDC 82725-4051). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
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
Warnings
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
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use
Stop use and ask a doctor if
have trouble urinating or emptying your bladder
an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding,
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)
Dosage & Administration
Directions
adults 65 years and over:
- ask a doctor
- take 1 tablet (5mg) once daily in the evening
- do not take more than 1 tablet (5mg) in 24 hours
- 1./2 tablet (2.5mg) once daily in the evening may be appropriate for less severe symptoms
- take ½ tablet (2.5mg) once daily in the evening
- do not take more than ½ tablet (2.5mg) in 24 hours
- Do not use
- do not use
adults and children 12-64 years of age:
children 6-11 years of age:
Children under 6 years of age:
Consumers with liver or kidney disease:
Other Safety Information
Other information
- store between 20° and 25°C (68°and 77°F)
- safety sealed: do not use if opened
Inactive Ingredient
Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, silicon dioxide, titanium dioxide
Package Label.Principal Display Panel
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Label:
Label Image (82725 4051 1)
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