Label: ALLERGY RELIEF- levocetirizine dihydrochloride tablet
- NDC Code(s): 73581-201-80
- Packager: YYBA CORP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 16, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Uses
-
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
-
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
- ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
CHILDREN 6-11 YEARS OF AGE
- 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 OF AGE
- DO NOT USE
CONSUMERS WITH KIDNEY DISEASE
- DO NOT USE
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
levocetirizine dihydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73581-201 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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 8mm Flavor Imprint Code LL;H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73581-201-80 1 in 1 BOX 06/30/2020 1 180 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 ANDA213513 06/30/2020 Labeler - YYBA CORP (006339772) Establishment Name Address ID/FEI Business Operations Hetero Labs Limited 676162024 manufacture(73581-201)
