Label: CETIRIZINE capsule, liquid filled
- NDC Code(s): 0363-1040-02, 0363-1040-04
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 26, 2021
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- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- 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 capsule once daily; do not take more than one 10 mg capsule 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
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INGREDIENTS AND APPEARANCE
CETIRIZINE
cetirizine capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1040 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM HYDROXIDE (UNII: 55X04QC32I) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) Sorbitol (UNII: 506T60A25R) Mannitol (UNII: 3OWL53L36A) WATER (UNII: 059QF0KO0R) 1,4-Sorbitan (UNII: AV0YTZ4E6J) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color YELLOW (natural) Score no score Shape OVAL Size 13mm Flavor Imprint Code 10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1040-02 1 in 1 CARTON 07/03/2017 01/31/2023 1 25 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-1040-04 1 in 1 BLISTER PACK 07/03/2017 05/31/2023 2 40 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207235 07/03/2017 05/31/2023 Labeler - Walgreens (008965063) Registrant - Apotex Inc. (209429182)