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
- Manufacturer
- Apotex Corp. | Apotex Inc.
- Effective date
- 2021-02-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:53:56
Label at a glance#
ProductCetirizine
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure11 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
Contacts and useful links#
Label contents#
Full prescribing information#
SPL PRODUCT DATA ELEMENTS SECTION
SPL UNCLASSIFIED SECTION
Active ingredient (in each capsule)
Cetirizine HCl 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
OTC - DO NOT USE SECTION
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
OTC - STOP USE SECTION
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° to 25°C (68° to 77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- protect from light
Inactive ingredients
butylated hydroxytoluene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol
Questions or comments?
call 1-800-706-5575 Monday to Friday 9 AM to 5 PM EST
Principal Display Panel
Cetirizine HCl Capsules 10 mg
Antihistamine
65 Liquid Filled Capsules/10 mg each
Indoor & Outdoor Allergies
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watry Eyes
- Itchy Throat or Nose
Principal Display Panel
Cetirizine HCl Capsules 10 mg
Antihistamine
65 Liquid Filled Capsules/10 mg each
Indoor & Outdoor Allergies
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watry Eyes
- Itchy Throat or Nose
Products#
Every source-derived product name is available through these pages.
- Cetirizine
- CETIRIZINE HYDROCHLORIDE
- POLYETHYLENE GLYCOL 400
- SODIUM HYDROXIDE
- BUTYLATED HYDROXYTOLUENE
- GELATIN, UNSPECIFIED
- SORBITOL
- MANNITOL
- WATER
- 1,4-SORBITAN
- SHELLAC
- TITANIUM DIOXIDE
- ISOPROPYL ALCOHOL
- BUTYL ALCOHOL
- PROPYLENE GLYCOL
- AMMONIA N-13
- DIMETHICONE
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60505-4668 | 60505-4668-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| SORBITOL | 506T60A25R | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| WATER | 059QF0KO0R | IACT |
| 1,4-SORBITAN | AV0YTZ4E6J | IACT |
| SHELLAC | 46N107B71O | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| BUTYL ALCOHOL | 8PJ61P6TS3 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| AMMONIA N-13 | 9OQO0E343Z | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|---|
| A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | 2016-08-12 |
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 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207235-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | 2016-08-12 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| c7ca2e17-5968-18b0-8d37-8bf875adc114 | 5ddd5bfe-eb1b-2129-decc-eec4788c956d | 2021-02-03 | Warnings | c7ca2e17-5968-18b0-8d37-8bf875adc114 5ddd5bfe-eb1b-2129-decc-eec4788c956d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.