Label: CETIRIZINE HYDROCHLORIDE tablet
- NDC Code(s): 63187-110-30, 63187-110-60, 63187-110-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 51660-939
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 1, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
-
WARNINGS
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 a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.
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
an allergic reaction to this product occurs. Seek medical help right away.
-
DIRECTIONS
adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over: ask a doctor
children under 6 years of age: ask a doctor
consumers with liver or kidney disease: ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
-
PRINCIPAL DISPLAY PANEL
†Compare to the active ingredient of Zyrtec®
NDC 63187-110-90
Original Prescription Strength
Cetirizine HCl Tablets, 10 mg
Antihistamine
Allergy
Indoor & Outdoor Allergies
24 Hour
Relief of:
- •
- Sneezing
- •
- Runny Nose
- •
- Itchy, Watery Eyes
- •
- Itchy Throat or Nose
90 TABLETS 10 mg EACH
†This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec®. Zyrtec® is a registered trademark of UCB Pharma, S.A.
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-110(NDC:51660-939) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white Score no score Shape RECTANGLE (rounded-off) Size 9mm Flavor Imprint Code RI52 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-110-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 2 NDC:63187-110-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/09/2021 3 NDC:63187-110-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077498 12/27/2007 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-110) , RELABEL(63187-110)