Label: CETIRIZINE HCL capsule
- NDC Code(s): 30142-995-25, 30142-995-40, 30142-995-50
- Packager: KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 19, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Uses
-
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
- 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.
-
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?
-
SPL UNCLASSIFIED SECTION
Zyrtec® is a registered trademark of Johnson & Johnson
Corporation, New Brunswick, New Jersey 08933. Johnson & Johnson
Corporation is not affiliated with The Kroger Co. or this product.
DISTRIBUTED BY
THE KROGER CO.,
CINCINNATI,
OHIO 45202
QUALITY GUARANTEE
800-632-6900
www.kroger.com
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP THIS CARD FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION
L0000553
R0122
-
Principal Display Panel
COMPARE TO the active ingredient
of ZYRTEC® LIQUID GELS *See back panelKroger
All Day
AllergyCetirizine Hydrochloride
Capsules, 10 mgAntihistamine
INDOOR & OUTDOOR
ALLERGIES
24 HOUR RELIEF OF:
Sneezing, Runny Nose; Itchy, Watery Eyes
& Itchy Throat or Nose
24
HOUR
SYMPTOM
RELIEF
actual size
40 SOFTGELS†
†liquid-filled capsules
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HCL
cetirizine hcl capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-995 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:30142-995-25 1 in 1 CARTON 06/03/2019 1 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:30142-995-40 1 in 1 CARTON 06/03/2019 2 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:30142-995-50 1 in 1 CARTON 06/03/2019 3 50 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 06/03/2019 Labeler - KROGER COMPANY (006999528) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(30142-995)