Label: LEVOCETIRIZINE DIHYDROCHLORIDE tablet, coated
- NDC Code(s): 30142-717-16, 30142-717-35, 30142-717-80
- Packager: KROGER COMPANY
- This is a repackaged label.
- Source NDC Code(s): 43598-735
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 10, 2023
If you are a consumer or patient please visit this version.
- 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?
- Carton Label
- Bottle Label
-
INGREDIENTS AND APPEARANCE
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-717(NDC:43598-735) 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 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-717-35 1 in 1 CARTON 09/30/2018 1 35 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:30142-717-16 2 in 1 CARTON 09/30/2018 2 NDC:30142-717-80 80 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210375 09/30/2018 Labeler - KROGER COMPANY (006999528)