Label: 24 HOUR ALLERGY- cetirizine hydrochloride tablet, film coated
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NDC Code(s):
41250-458-13,
41250-458-39,
41250-458-58,
41250-458-66, view more41250-458-72, 41250-458-75, 41250-458-87, 41250-458-95
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 5, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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.
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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 or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
24 HOUR ALLERGY
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-458 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 STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color WHITE Score no score Shape OVAL Size 10mm Flavor Imprint Code 4H2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-458-66 14 in 1 CARTON 01/11/2008 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41250-458-39 1 in 1 CARTON 12/19/2008 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:41250-458-95 1 in 1 CARTON 08/15/2008 10/31/2022 3 45 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:41250-458-72 1 in 1 CARTON 07/07/1997 4 60 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:41250-458-75 2 in 1 CARTON 08/15/2008 5 45 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:41250-458-87 1 in 1 PACKAGE 08/27/2008 6 300 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:41250-458-58 1 in 1 CARTON 02/27/2014 7 40 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:41250-458-13 5 in 1 CARTON 10/13/2020 8 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078336 07/07/1997 Labeler - Meijer Distribution Inc (006959555)