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
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
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
store at 20º-25°C (68º-77°F) avoid high humidity and excessive heat above 40ºC (104ºF) protect from light
Cetirizine HCl 10 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
liver or kidney disease. Your doctor should determine if you need a different dose.
taking tranquilizers or sedatives.
an allergic reaction to this product occurs. Seek medical help right away.
In case of overdose, get medical help or contact a Poison Control Center right away.
| 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 |
FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol
1-248-449-9300 Monday-Friday 9AM-5PM EST
*Compare to the active ingredient in ZYRTEC®
All Day Allergy Relief
Indoor & Outdoor Allergies
Cetirizine HCl Capsules, 10 mg
Antihistamine
24 Hour Relief of:
SOFTGELS**
(**Liquid-filled capsules)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Zyrtec®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-139-25 | EA - Each | 63868-139 | a07391bc-1d4f-418d-81c3-1989643d3d53 | 1 | 2022-06-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63868-139 | 63868-139-25 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | |
| N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | |
| N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | |
| N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 |
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 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | CAPSULE / ORAL | RLD | 2009-07-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022429-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | CAPSULE / ORAL | RLD, RS | 2009-07-23 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| d357d8bf-bd25-49d7-8b06-b20f2738914c | f1bd742d-06c8-40f4-8e88-d9cebde45a0d | 2021-11-02 | Warnings | d357d8bf-bd25-49d7-8b06-b20f2738914c f1bd742d-06c8-40f4-8e88-d9cebde45a0d |
Adverse event summaries are temporarily unavailable. Other product information remains available.