Label: LEVOCETIRIZINE DIHYDROCHLORIDE- levocetirizine dihydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 42571-312-11, 42571-312-18, 42571-312-32, 42571-312-53, view more42571-312-90 - Packager: Micro Labs Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 7, 2019
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 a doctor if
- you have trouble urinating or emptying your bladder
- an allergic reaction to this product occurs. Seek medical help right away.
- DO NOT USE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- KEEP OUT OF REACH OF CHILDREN
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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 than1 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
- STORAGE
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
MICRO LABS LIMITED
Container
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine90 Tablets MICRO LABS
Container-Carton
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine90 Tablets MICRO LABS
INVATECH PHARMA SOLUTIONS LLC
Container
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine90 Tablets MICRO LABS
Container-Carton
NDC- 42571-312-90
Levocetirizine dihydrochloride Tablets USP
5mg
Antihistamine90 Tablets MICRO LABS
-
INGREDIENTS AND APPEARANCE
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42571-312 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color white (White to off-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:42571-312-53 2500 in 1 POUCH; Type 0: Not a Combination Product 02/01/2019 2 NDC:42571-312-90 1 in 1 CARTON 02/01/2019 2 90 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:42571-312-11 100 in 1 CARTON 02/01/2019 3 NDC:42571-312-32 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:42571-312-18 1 in 1 CARTON 02/01/2019 4 10 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 02/01/2019 Labeler - Micro Labs Limited (862174955) Establishment Name Address ID/FEI Business Operations InvaTech Pharma Solutions LLC 078602180 manufacture(42571-312) Establishment Name Address ID/FEI Business Operations Micro Labs Limited 915793658 manufacture(42571-312)