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NDC 58602-0446-09 Cetirizine Hydrochloride (Hives Relief) 5 mg/1 Details

Cetirizine Hydrochloride (Hives Relief) 5 mg/1

Cetirizine Hydrochloride (Hives Relief) is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. 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: 58602-0446-09
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	58602-0446
Product ID	58602-446_667df879-9494-4c60-8b28-1cedec09bab0
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 (Hives Relief)
Proprietary Name Suffix	n/a
Non-Proprietary Name	Cetirizine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	Aurohealth LLC
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090760
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58602-0446-09 (58602044609)

Pricing Information	N/A
NDC Package Code	58602-446-09
Billing NDC	58602044609
Package	1 BOTTLE in 1 CARTON (58602-446-09) / 30 TABLET in 1 BOTTLE
Marketing Start Date	2015-08-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

For 5 mg:

Cetirizine hydrochloride USP 5 mg

For 10 mg:

Cetirizine hydrochloride USP 10 mg

Purpose

Antihistamine

Uses

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

trouble swallowing
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
trouble speaking
drooling
wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

to prevent hives from any known cause such as:
- foods
- insect stings
- medicines
- latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

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.
hives that are an unusual color, look bruised or blistered
hives that do not itch

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.
symptoms do not improve after 3 days of treatment.
the hives have lasted more than 6 weeks.

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. [1-800-222-1222]

Directions

For 5 mg:

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours.
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

For 10 mg:

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)
TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

call 1-855-274-4122

Keep the carton. It contains important information.

Manufactured for:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 072, India

M.L.No.: 19/HD/AP/95/F/R

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

AUROHEALTH

Original Prescription Strength                 NDC 58602-446-09

Cetirizine

Hydrochloride

Tablets USP 5 mg

Antihistamine HIVES Relief

24 hour

Relief of Itching

Due to Hives

30

Tablets

5 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label)

AUROHEALTH

NDC 58602-446-21

Original Prescription Strength

Cetirizine

Hydrochloride

Tablets USP

5 mg

Antihistamine

HIVES Relief

24 hour

Relief of Itching Due to Hives

100 (10 x 10) Unit-dose Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

AUROHEALTH

Original Prescription Strength

NDC 58602-447-09

Cetirizine

Hydrochloride

Tablets USP 10 mg

Antihistamine

6 yrs & older

HIVES Relief

24 hour

Relief of itching

Due to Hives

30

Tablets

10 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

AUROHEALTH

NDC 58602-447-21

Original Prescription Strength

Cetirizine

Hydrochloride

Tablets USP

10 mg

Antihistamine

6 yrs & older

HIVES Relief

24 hour

Relief of Itching Due to Hives

100 (10 x 10) Unit-dose Tablets

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)

cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-446
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	X;35
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-446-09	1 in 1 CARTON	08/05/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:58602-446-17	1 in 1 CARTON	08/05/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:58602-446-47	75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	08/05/2015
4	NDC:58602-446-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
5	NDC:58602-446-21	10 in 1 CARTON	08/05/2015
5		10 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	ANDA090760	08/05/2015

CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)

cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-447
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	X;36
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-447-09	1 in 1 CARTON	08/05/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:58602-447-17	1 in 1 CARTON	08/05/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:58602-447-47	75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	08/05/2015
4	NDC:58602-447-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
5	NDC:58602-447-21	10 in 1 CARTON	08/05/2015
5		10 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	ANDA090760	08/05/2015

CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)

cetirizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-813
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White to Off-white)	Score	2 pieces
Shape	RECTANGLE (off-rectangular)	Size	9mm
Flavor		Imprint Code	X;2;0
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-813-09	1 in 1 CARTON	08/05/2015
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:58602-813-17	1 in 1 CARTON	08/05/2015
2		45 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:58602-813-99	75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	08/05/2015
4	NDC:58602-813-23	1 in 1 CARTON	08/05/2015
4		120 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:58602-813-39	1 in 1 CARTON	08/05/2015
5		365 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:58602-813-41	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2015
7	NDC:58602-813-04	10 in 1 CARTON; Type 0: Not a Combination Product	08/05/2015
8	NDC:58602-813-83	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/05/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090760	08/05/2015

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		918917642	ANALYSIS(58602-446, 58602-447, 58602-813) , MANUFACTURE(58602-446, 58602-447, 58602-813)

Revised: 11/2022

Document Id: 667df879-9494-4c60-8b28-1cedec09bab0

Set id: 2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a

Version: 4

Effective Time: 20221103

Search by Drug Name or NDC

NDC 58602-0446-09 Cetirizine Hydrochloride (Hives Relief) 5 mg/1 Details

Cetirizine Hydrochloride (Hives Relief) 5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 58602-0446-09 (58602044609)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Do not use

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?

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

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