Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablets tablet, film coated
- NDC Code(s): 68788-8435-3, 68788-8435-6, 68788-8435-9
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 43598-811
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining hydroxyzine.
Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
- 1.
- drowsiness may occur
- 2.
- avoid alcoholic drinks
- 3.
- alcohol, sedatives, and tranquilizers may increase drowsiness
- 4.
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
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?
- Bottle Label
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablets tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8435(NDC:43598-811) 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 7mm Flavor Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-8435-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2023 2 NDC:68788-8435-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2023 3 NDC:68788-8435-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078343 04/27/2023 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-8435)