Drug Facts Active Ingredient (In Each Tablet)
Levocetirizine dihydrochloride USP 5 mg
Levocetirizine Dihydrochloride Tablet, Film Coated
FDA Label NDC 85786-206
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Levocetirizine Dihydrochloride (NDC 85786-206). 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, stop use and ask a doctor if, 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
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
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 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 ■ 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms |
| children 6 to 11 years of age | ■ take 1/2 tablet (2.5 mg) once daily in the evening
■ do not take more than 1/2 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 individual blister unit is open or torn
Inactive Ingredients
Colloidal silicone dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.
Questions Or Comments?
(855)-280-1079
Principal Display Panel
NDC: 85786-206-30
DR. SIMI
Allergy Relief
Levocetirizine Dihydrochloride
Tablets, USP 5 mg
Antihistamine
24 HOUR Relief of: • Sneezing • Runny Nose • Itchy Nose or Throat • Itchy, Watery Eyes
30 Tablets
Compare to XYZAL® 24 HR Active Ingredient*
*This product is not manufactured or distributed by Chattem, Inc. owner of the registered trademark XYZAL® Allergy 24HR.
Read directions and warnings before use.
Keep this carton.
It has important information.
Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
* Please review the disclaimer below.
