Allergy Relief

Manufacturer
FSA STORE INC.
Effective date
2025-03-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:56:54

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

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

WARNINGS SECTION

Warnings

Directions And Dosage

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 Label Information

Other information

store between 20 to 25°C (68 to 77°F) retain carton for complete product information and warnings

Inactive ingredients

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

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

caring mill™ NDC 81522-194-04 †Compare to the active ingredient of Zyrtec® Allergy Allergy Relief Cetirizine Hydrochloride Tablets, 10 mg Antihistamine 24 Hour Relief of: • Sneezing • Runny nose • Itchy, watery eyes • Itchy throat or nose • Original prescription strength • Indoor and outdoor allergies Actual Size 45 TABLETS

Label Images#

F1194A04CRM_R0
F1194A04CRM_R0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD3
1014678cetirizine HCl 10 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-194-04Allergy Relief1 in 1 CARTONTABLET, COATED13
81522-194-04Allergy Relief45 in 1 BOTTLE, PLASTICTABLET, COATED453
81522-194-16Allergy Relief1 in 1 CARTONTABLET, COATED13
81522-194-16Allergy Relief90 in 1 BOTTLE, PLASTICTABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-194ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [FSA STORE INC.]3Current NDC, Legacy NDC, 4 package rows20250309_ec6b4e86-ac27-e1f2-e053-2a95a90ab3e1.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81522-19481522-194-04, 81522-194-16

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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 SECTION

WARNINGS SECTION

Warnings

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store between 20 to 25°C (68 to 77°F) retain carton for complete product information and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-844-705-4384

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

caring mill™ NDC 81522-194-04 †Compare to the active ingredient of Zyrtec® Allergy Allergy Relief Cetirizine Hydrochloride Tablets, 10 mg Antihistamine 24 Hour Relief of: • Sneezing • Runny nose • Itchy, watery eyes • Itchy throat or nose • Original prescription strength • Indoor and outdoor allergies Actual Size 45 TABLETS

Source Document#

Source XML