Label: CETIRIZINE HYDROCHLORIDE capsule, liquid filled
- NDC Code(s): 59556-894-12, 59556-894-77, 59556-894-78, 59556-894-79
- Packager: Strides Pharma Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 10, 2023
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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.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
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.
If pregnant or breast-feeding:
- if breast-feeding: not recommended.
- if pregnant: ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
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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
- Questions or comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-894 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 GELATIN (UNII: 2G86QN327L) ISOPROPYL ALCOHOL (UNII: ND2M416302) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW (colorless to pale yellow) Score no score Shape OVAL Size 14mm Flavor Imprint Code 291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-894-12 1 in 1 CARTON 07/21/2017 1 40 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:59556-894-77 1 in 1 CARTON 05/21/2018 2 12 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:59556-894-79 7000 in 1 BAG; Type 0: Not a Combination Product 05/21/2018 4 NDC:59556-894-78 1 in 1 CARTON 05/21/2018 4 25 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 ANDA205291 07/21/2017 Labeler - Strides Pharma Inc (078868278) Establishment Name Address ID/FEI Business Operations Strides Pharma Science Limited 918513263 ANALYSIS(59556-894) , MANUFACTURE(59556-894) , PACK(59556-894)
