Label: CETIRIZINE HCL capsule
- NDC Code(s): 46122-613-63
- Packager: AMERISOURCE BERGEN
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated June 18, 2019
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- Active ingredient (in each capsule)
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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- 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
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?
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of ZYRTEC®
1300 Morris Drive
Chesterbrook, PA 19087
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INGREDIENTS AND APPEARANCE
cetirizine hcl capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-613 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 FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color orange Score no score Shape OVAL Size 13mm Flavor Imprint Code CE1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-613-63 1 in 1 CARTON 06/18/2019 1 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022429 06/18/2019 Labeler - AMERISOURCE BERGEN (007914906) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(46122-613)