Indications and 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
CETIRIZINE - KROGER COMPANY | Aurohealth LLC | Aurobindo Pharma Limited
- Manufacturer
- KROGER COMPANY | Aurohealth LLC | Aurobindo Pharma Limited
- Effective date
- 2026-07-15
- Label type
- Human OTC Drug Label
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-07-18 05:11:29
Label at a glance#
ProductCetirizine Hydrochloride (Allergy)
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure17 sections
Dosage and administration
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
Storage and handling
store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Cetirizine hydrochloride USP 10 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
| 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 or comments?
Call 1-800-632-6900
PROUDLY DISTRIBUTED
BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Label)
NDC 30142-172-09
KROGER®
health
ORIGINAL PRESCRIPTION STRENGTH
Allergy Relief
Cetirizine Hydrochloride
Tablets USP 10 mg
Antihistamine
30 TABLETS, 10 mg EACH
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)
NDC 30142-172-09
KROGER®
health
COMPARE TO THE ACTIVE
INGREDIENT OF ZYRTEC®†
ORIGINAL PRESCRIPTION STRENGTH
Allergy Relief
Cetirizine Hydrochloride
Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies
10 mg Strength Tablets
24 HR
RELIEF
RELIEF OF: SNEEZING
RUNNY NOSE
ITCHY, WATERY EYES
ITCHY THROAT OR NOSE
ACTUAL SIZE
30 TABLETS
10 mg EACH
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
Products#
Every source-derived product name is available through these pages.
- Cetirizine Hydrochloride (Allergy)
- Cetirizine Hydrochloride
- CETIRIZINE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- HYPROMELLOSE 2910 (5 MPA.S)
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 400
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 30142-172 | 30142-172-09, 30142-172-54 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2021-04-15 | full-release | 2026-05-31 23:39:42 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-08-05 | ||
| A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-08-05 | ||
| A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2015-08-05 | ||
| A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2015-08-05 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cetirizine Hydrochloride (Allergy) | CETIRIZINE HYDROCHLORIDE | KROGER COMPANY | b92d959d-dd35-b2a3-e053-2995a90af3ff | 2026-07-15 | Warnings | 30142-172-09 30142-172-54 30142-172 30142017209 30142017254 05203ede-e178-4663-aaf9-c0b155a38707 b92d959d-dd35-b2a3-e053-2995a90af3ff |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.