Label: LEVOCETIRIZINE DIHYDROCHLORIDE tablet, coated
- NDC Code(s): 0363-5528-10, 0363-5528-35, 0363-5528-55, 0363-5528-80
- Packager: Walgreens Company
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 11, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
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 doctor if
- you have trouble urinating or emptying your bladder
- an allergic reaction to this product occurs. Seek medical help right away.
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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
- 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 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
- Inactive ingredients
- Questions or comments?
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Carton Label
ORIGINAL PRESCRIPTION STRENGTH
Compare to Xyzal®Allergy 24HR active ingredient‡‡0363-5528-35
NEW Well at Walgreens
WALGREENS PHARMACIST RECOMMENDED‡ORIGINAL
PRESCRIPTION
STRENGTHLevocetirizine
24-Hour AllergyLevocetirizine Dihydrochloride
Tablets, 5 mg / AntihistamineRelief of:
- Sneezing
- Runny nose
- Itchy nose or throat
- Itchy, watery eyes
24 HOUR
35 TABLETS
- Bottle Label
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INGREDIENTS AND APPEARANCE
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5528 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength levocetirizine dihydrochloride (UNII: SOD6A38AGA) (levocetirizine - UNII:6U5EA9RT2O) levocetirizine dihydrochloride 5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSES (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) Product Characteristics Color white Score 2 pieces Shape OVAL Size 9mm Flavor Imprint Code L;L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-5528-35 1 in 1 CARTON 03/12/2018 09/06/2019 1 35 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-5528-55 1 in 1 CARTON 03/12/2018 09/06/2019 2 55 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0363-5528-80 1 in 1 CARTON 03/12/2018 09/06/2019 3 80 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0363-5528-10 2 in 1 CARTON 04/17/2018 09/06/2019 4 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210375 03/12/2018 Labeler - Walgreens Company (008965063)