Label: CURIST ALLERGY RELIEF- levocetirizine dihydrochloride tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 72559-007-05 - Packager: Little Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 25, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
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.
-
DOSAGE & ADMINISTRATION
Directions
adults 65 years and older ask a doctor
adults and children 12-64 years - take 1 tablet (5 mg) once daily in the evening
- do not take more than 1 tablet (5 mg) in 24 hours
- ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years - take ½ tablet (2.5 mg) once daily in the evening
- do not take more than ½ tablet (2.5 mg) in 24 hours
children under 6 years do not use consumers with kidney disease do not use - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CURIST ALLERGY RELIEF
levocetirizine dihydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72559-007 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score 2 pieces Shape OVAL Size 8mm Flavor Imprint Code LI Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72559-007-05 1 in 1 CARTON 10/15/2019 1 90 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 ANDA211551 10/15/2019 Labeler - Little Pharma, Inc. (074328189)