Label: GOOD SENSE LEVOCETIRIZINE- levocetirizine dihydrochloride tablet, film coated
- NDC Code(s): 0113-0241-01
- Packager: L. Perrigo Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 15, 2020
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- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
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- if you have kidney disease
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- 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
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- drowsiness may occur
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- avoid alcoholic drinks
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
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- you have trouble urinating or emptying your bladder
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- an allergic reaction to this product occurs. Seek medical help right away.
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Directions
adults 65 years of age and older
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- ask a doctor
adults and children 12-64 years of age
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- take 1 tablet (5 mg) once daily in the evening
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- do not take more than 1 tablet (5 mg) in 24 hours
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- ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age
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- take ½ tablet (2.5 mg) once daily in the evening
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- do not take more than ½ tablet (2.5 mg) in 24 hours
children under 6 years of age
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- do not use
consumers with kidney disease
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- do not use
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
GOOD SENSE LEVOCETIRIZINE
levocetirizine dihydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0241 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score 2 pieces Shape OVAL Size 8mm Flavor Imprint Code L9CZ;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-0241-01 1 in 1 CARTON 09/11/2020 1 35 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 ANDA211983 09/11/2020 Labeler - L. Perrigo Company (006013346)