MedPath

Allergy Relief

692R_Albertsons_21130-712_Cetirizine HCL Tablets 10mg

Approved
Approval ID

eb60ae7d-87db-7413-e053-2a95a90afd76

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 28, 2025

Manufacturers
FDA

BETTER LIVING BRANDS, LLC

DUNS: 009137209

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cetirizine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21130-712
Application NumberANDA078933
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cetirizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2025
FDA Product Classification

INGREDIENTS (8)

HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CETIRIZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 64O047KTOA
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2023

![692R-Albertsons-Cetrizine HCl-30s-Carton](/dailymed/image.cfm?name=692R-Albertsons- Cetrizine+HCl-30s-Carton.jpg&id=890527)

![692R-Albertsons-Cetrizine HCl-30s-Label.jpg](/dailymed/image.cfm?name=692R-Albertsons- Cetrizine+HCl-30s-Label.jpg&id=890527)

![692R-Albertsons-Cetrizine HCl-45s-Carton](/dailymed/image.cfm?name=692R-Albertsons- Cetrizine+HCl-45s-Carton.jpg&id=890527)

![692R-Albertsons-Cetrizine HCl-45s-Label](/dailymed/image.cfm?name=692R-Albertsons- Cetrizine+HCl-45s-Label.jpg&id=890527)

![692R-Albertsons-Cetrizine HCl-120s-Carton](/dailymed/image.cfm?name=692R-Albertsons- Cetrizine+HCl-120s-Carton.jpg&id=890527)

![692R-Albertsons-Cetrizine HCl-120s-Label](/dailymed/image.cfm?name=692R-Albertsons- Cetrizine+HCl-120s-Label.jpg&id=890527)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/21/2023

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/21/2023

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/25/2023

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/22/2023

If pregnant or breast-feeding

  • if breast-feeding: Not recommended
  • if pregnant: Ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/25/2023

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).

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/21/2023

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 5/25/2023

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/25/2023

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/25/2023

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/25/2023

Purpose

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 5/21/2023

Warnings

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/25/2023

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/25/2023

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 SAFETY INFORMATION

LOINC: 60561-8Updated: 5/23/2023

Other information

  • store between 20° to 25°C (68° to 77°F).

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/21/2023

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/25/2023

**Questions or comments?**1-877-290-4008

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