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 Hydrochloride (Allergy)
- Manufacturer
- KROGER COMPANY | Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED
- Effective date
- 2021-03-29
- Label type
- Human OTC Drug Label
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:48:23
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 capsule once daily; do not take more than one 10 mg capsule 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 at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Cetirizine HCl Capsules 10 mg (Allergy)
Drug Facts
Active ingredient (in each capsule)
Cetirizine HCI 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.
OTC - ASK DOCTOR SECTION
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
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 capsule once daily; do not take more than one 10 mg capsule 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 at 20°-25°C (68°-77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- protect from light
- do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.
Inactive ingredients
black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution
Questions or comments?
1-800-632-6900
DISTRIBUTED BY THE KROGER CO.,
CINCINNATI, OHIO 45202
MADE IN INDIA
Code: TS/DRUGS/14/2014
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label)
NDC 30142-169-53
Kroger®
ORIGINAL PRESCRIPTION STRENGTH
Allergy
Cetirizine HCl Capsules,
10 mg
Antihistamine
INDOOR & OUTDOOR ALLERGIES
24
HOUR
RELIEF
READ AND KEEP THE OUTER PACKAGE FOR
COMPLETE WARNINGS AND INFORMATION
25
LIQUID GELS**
**liquid-filled capsules
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (25's Capsule Container Carton Label)
COMPARE TO the active ingredient
of ZYRTEC®
*See back panel NDC 30142-169-53
Kroger®
ORIGINAL
PRESCRIPTION
STRENGTH
Allergy
Cetirizine HCl Capsules,
10 mg
Antihistamine
INDOOR & OUTDOOR
ALLERGIES
24 HOUR
RELIEF OF:
Sneezing, Runny Nose ; Itchy,
Watery Eyes & Itchy Throat
or Nose
CZ10
actual size
24
HOUR
RELIEF
25
LIQUID GELS**
** liquid-filled capsules
Products#
Every source-derived product name is available through these pages.
- Cetirizine Hydrochloride (Allergy)
- Cetirizine Hydrochloride
- CETIRIZINE
- FERROSOFERRIC OXIDE
- GELATIN, UNSPECIFIED
- GLYCERIN
- HYPROMELLOSE 2910 (6 MPA.S)
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- WATER
- SODIUM HYDROXIDE
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 30142-169 | 30142-169-53, 30142-169-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SORBITOL | 506T60A25R | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|---|
| A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | 2018-07-20 | ||
| A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | 2018-07-20 |
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 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209107-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2018-07-20 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209107-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | 2018-07-20 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| 97466341-1414-429b-b330-236d34fec176 | b92d0f1e-9aee-e6d5-e053-2a95a90a79d7 | 2024-01-18 | Warnings | b92d0f1e-9aee-e6d5-e053-2a95a90a79d7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.