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NDC 49035-0276-01 Equate 5 mg/5mL Details

Equate 5 mg/5mL

Equate is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. 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: 49035-0276-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine

Product Information

NDC	49035-0276
Product ID	49035-276_8d295913-8dd6-43cd-ae46-9b5a8ba2e60d
Associated GPIs	41550020102010
GCN Sequence Number	021687
GCN Sequence Number Description	cetirizine HCl SOLUTION 1 MG/ML ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	49290
HICL Sequence Number	006544
HICL Sequence Number Description	CETIRIZINE HCL
Brand/Generic	Generic
Proprietary Name	Equate
Proprietary Name Suffix	Childrens Allergy Relief
Non-Proprietary Name	Cetirizine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/5mL
Substance Name	CETIRIZINE HYDROCHLORIDE
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090182
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0276-01 (49035027601)

Pricing Information	N/A
NDC Package Code	49035-276-01
Billing NDC	49035027601
Package	1 BOTTLE in 1 CARTON (49035-276-01) / 240 mL in 1 BOTTLE
Marketing Start Date	2011-09-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b73950f4-af6f-4dc7-bce2-9ec43c45eee5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 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
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. (1-800-222-1222)

Directions

use only with enclosed dosing cup
find right dose on chart below
mL = milliliter

adults and children 6 years and over	5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over	5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age	2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

do not use if carton is opened or if imprinted safety seal is broken or missing
see bottom panel for lot number and expiration date
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

Questions?

1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 49035-276-09

equate™

Compare to

Children's

Zyrtec® active

ingredient*

children*s

CETIRIZINE

HYDROCHLORIDE

ORAL SOLUTION

1 mg/mL

Antihistamine (Allergy)

2 YEARS AND OLDER

24 Hour Relief of:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

LASTS UP TO

24

HOURS

Indoor and

Outdoor Allergies

Sugar Free

Dye Free

Grape

Flavor

4 FL OZ (120 mL)

Dosage Cup

Included

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

EQUATE CHILDRENS ALLERGY RELIEF

cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-276
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 in 5 mL

Ingredient Name	Strength
Inactive Ingredients
acetic acid (UNII: Q40Q9N063P)
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium acetate anhydrous (UNII: NVG71ZZ7P0)
sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor	GRAPE (sugar free)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-276-01	1 in 1 CARTON	09/08/2011
1		240 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:49035-276-08	1 in 1 CARTON	09/08/2011
2		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:49035-276-09	1 in 1 CARTON	04/05/2021
3		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:49035-276-02	1 in 1 CARTON	04/05/2021
4		240 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090182	09/08/2011

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 4/2021

Document Id: 8d295913-8dd6-43cd-ae46-9b5a8ba2e60d

Set id: b73950f4-af6f-4dc7-bce2-9ec43c45eee5

Version: 6

Effective Time: 20210406

Search by Drug Name or NDC

NDC 49035-0276-01 Equate 5 mg/5mL Details

Equate 5 mg/5mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49035-0276-01 (49035027601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b73950f4-af6f-4dc7-bce2-9ec43c45eee5 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 5 mL)

Purpose

Uses

Warnings

When using this product

If pregnant or breast-feeding

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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