Search by Drug Name or NDC

NDC 55111-0351-30 Cetirizine Hydrochloride 10 mg/1 Details

Cetirizine Hydrochloride 10 mg/1

Cetirizine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Dr.Reddy's Laboratories Limited. 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: 55111-0351-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	55111-0351
Product ID	55111-351_36bfe6fc-ad7e-a44a-b24c-7b2bdc8d2067
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 Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetirizine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	Dr.Reddy's Laboratories Limited
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 55111-0351-30 (55111035130)

Pricing Information	N/A
NDC Package Code	55111-351-30
Billing NDC	55111035130
Package	1 BOTTLE in 1 CARTON (55111-351-30) / 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2008-01-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL de152651-bfcd-856a-8329-a2ac93a376bc Details

Active ingredient (in each tablet)

Cetirizine HCl, 10mg

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

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.

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 tablet once daily; do not take more than one 10 mg tablet 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 between 20° to 25°C (68° to 77°F)

Inactive ingredients

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.

Questions?

call 1-888-375-3784.

PRINCIPAL DISPLAY PANEL

Bottle label

PRINCIPAL DISPLAY PANEL

Carton label

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-699
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	C
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-699-90	1 in 1 CARTON	04/08/2008
1		90 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:55111-699-45	1 in 1 CARTON	04/08/2008
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:55111-699-30	1 in 1 CARTON	04/03/2008
3		30 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:55111-699-51	1 in 1 CARTON	07/22/2008
4		75 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:55111-699-04	1 in 1 CARTON	04/11/2008
5		120 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:55111-699-19	1 in 1 CARTON	01/15/2008
6		175 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:55111-699-47	2 in 1 CARTON	04/03/2008
7		175 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:55111-699-60	1 in 1 CARTON	04/07/2008
8		60 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:55111-699-73	1 in 1 CARTON	10/06/2010
9		365 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC:55111-699-52	1 in 1 CARTON	10/06/2010
10		14 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC:55111-699-74	2 in 1 CARTON	04/04/2008
11		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
12	NDC:55111-699-31	1 in 1 CARTON	09/27/2016
12		300 in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC:55111-699-15	1 in 1 CARTON	04/04/2008
13		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078343	01/15/2008

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-351
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RDY;351
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-351-30	1 in 1 CARTON	01/15/2008
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:55111-351-45	1 in 1 CARTON	01/15/2008
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:55111-351-60	1 in 1 CARTON	01/15/2008
3		60 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:55111-351-90	1 in 1 CARTON	01/15/2008
4		90 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:55111-351-04	1 in 1 CARTON	01/15/2008
5		120 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:55111-351-47	2 in 1 CARTON	01/15/2008
6		175 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:55111-351-51	1 in 1 CARTON	01/15/2008
7		75 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:55111-351-74	2 in 1 CARTON	01/15/2008
8		7 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078343	01/15/2008

Labeler - Dr.Reddy's Laboratories Limited (650562841)

Revised: 9/2011

Document Id: 36bfe6fc-ad7e-a44a-b24c-7b2bdc8d2067

Set id: de152651-bfcd-856a-8329-a2ac93a376bc

Version: 7

Effective Time: 20110930

Search by Drug Name or NDC

NDC 55111-0351-30 Cetirizine Hydrochloride 10 mg/1 Details

Cetirizine Hydrochloride 10 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 55111-0351-30 (55111035130)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL de152651-bfcd-856a-8329-a2ac93a376bc Details

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding:

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?