Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablets tablet, film coated
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NDC Code(s):
43598-811-05,
43598-811-12,
43598-811-13,
43598-811-15, view more43598-811-30, 43598-811-90
- Packager: Dr. Reddy's Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 22, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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?
- Carton
- Bottle Label
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablets tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) 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 HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (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:43598-811-30 1 in 1 CARTON 12/17/2018 1 300 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:43598-811-05 1 in 1 CARTON 12/17/2018 2 500 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:43598-811-90 1 in 1 CARTON 12/17/2018 3 90 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:43598-811-12 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/03/2019 5 NDC:43598-811-15 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/03/2019 6 NDC:43598-811-13 300 in 1 BOTTLE; Type 0: Not a Combination Product 09/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078343 12/17/2018 Labeler - Dr. Reddy's Laboratories Inc. (802315887)