Label: CETIRIZINE HYDROCHLORIDE tablet
- NDC Code(s): 71205-093-15, 71205-093-30, 71205-093-60, 71205-093-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 16571-401
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
- USES
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WARNINGS:
DO NOT USE
Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
ASK DOCTOR
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
WHEN USING THIS PRODUCT
- •
- drowsines may occur
- •
- avoid alcoholic drinks
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinary.
STOP USE
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
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DIRECTIONS
Adults and children 6years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
Adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in 24 hours
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor - OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Cetirizine Hydrochloride Tablets USP 5 mg
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-093(NDC:16571-401) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) magnesium stearate (UNII: 70097M6I30) starch, corn (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White) Score no score Shape BULLET (Barrel Shaped) Size 7mm Flavor Imprint Code CTN;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-093-15 15 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2018 2 NDC:71205-093-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2018 3 NDC:71205-093-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2018 4 NDC:71205-093-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 10/01/2009 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-093) , RELABEL(71205-093)