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NDC 30142-0995-40 Cetirizine HCl 10 mg/1 Details

Cetirizine HCl 10 mg/1

Cetirizine HCl is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by KROGER COMPANY. The primary component is CETIRIZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 30142-0995-40
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	30142-0995
Product ID	30142-995_df62c3c8-ab94-2b7f-e053-2a95a90a1caa
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cetirizine HCl
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetirizine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	KROGER COMPANY
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA022429
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0995-40 (30142099540)

Pricing Information	N/A
NDC Package Code	30142-995-40
Billing NDC	30142099540
Package	1 BOTTLE, PLASTIC in 1 CARTON (30142-995-40) / 40 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date	2019-06-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 63ddeea4-d701-42b2-bcb7-81c0e43eb013 Details

Active ingredient (in each capsule)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

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
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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center 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

store at 20º-25ºC (68º-77ºF)
avoid high humidity and excessive heat above 40ºC (104ºF)
protect from light

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

call toll free 1-800-632-6900

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 panel

Kroger

All Day

Allergy

Cetirizine Hydrochloride

Capsules, 10 mg

Antihistamine

INDOOR & OUTDOOR

ALLERGIES

24 HOUR RELIEF OF:

Sneezing, Runny Nose; Itchy, Watery Eyes

& Itchy Throat or Nose

HOUR

SYMPTOM

RELIEF

actual size

40 SOFTGELS†

†liquid-filled capsules

INGREDIENTS AND APPEARANCE

CETIRIZINE HCL

cetirizine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-995
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA022429	06/03/2019

Labeler - KROGER COMPANY (006999528)

Registrant - Bionpharma Inc. (079637826)

Name	Address	ID/FEI	Business Operations
Establishment
Patheon Softgels Inc.		002193829	manufacture(30142-995)

Revised: 5/2022

Document Id: df62c3c8-ab94-2b7f-e053-2a95a90a1caa

Set id: 63ddeea4-d701-42b2-bcb7-81c0e43eb013

Version: 3

Effective Time: 20220519