Label: ALLERGY RELIEF 24HR- levocetirizine dihydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 73226-001-00 - Packager: Vitesse Pharma LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 11, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- 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 a doctor if
- you have trouble urinating or emptying your bladder
- an allergic reaction to this product occurs. Seek medical help right away.
- if you have
kidney disease
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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
■ ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptomschildren 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 hourschildren under 6 years of age ■ do not use consumers with kidney disease ■ do not use (Note: Age ranges are bolded in the draft container labeling for tablet bottle)
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF 24HR
levocetirizine dihydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73226-001 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 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 X;X Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73226-001-00 40 in 1 CARTON 07/02/2019 1 2500 in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211551 07/02/2019 Labeler - Vitesse Pharma LLC (102376674)