Indications and uses
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Cetrizine Hydrochloride Tablets, 10 mg (Hives)
- Manufacturer
- Granules Pharmaceuticals Inc. | Granules India Ltd | GRANULES LIFE SCIENCES PRIVATE LIMITED
- Effective date
- 2026-10-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- daily-update
- Hydrated at
- 2026-10-07 01:02:19
Label at a glance#
ProductCetirizine hydrochloride - HIVES
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 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
Contacts and useful links#
Label contents#
Full prescribing information#
Cetirizine Hydrochloride Tablets
Drug Facts
Active ingredient (in each tablet)
Cetirizine HCl 10 mg
Purpose
Antihistamine
Uses
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Warnings
Severe Allergy Warning: Get emergency help
immediately if you have hives along with any of the following symptoms:
trouble swallowing
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
trouble speaking
drooling
wheezing or problems breathing These symptoms may be signs of anaphylactic shock.
This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
Do not use
to
prevent hives from any known cause such as:
foods
insect stings
medicines
latex or rubber gloves
because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
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.
hives that are an unusual color, look bruised or blistered
hives that do not itch
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
- in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
symptoms do not improve after 3 days of treatment
the hives have lasted more than 6 weeks
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)
◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
Questions?
call 1-877-770-3183: Weekdays 9:00 AM to 4:30 PM EST
PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Cetirizine hydrochloride - HIVES
- Cetirizine hydrochloride
- CETIRIZINE
- LACTOSE MONOHYDRATE
- CROSCARMELLOSE SODIUM
- SILICON DIOXIDE
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- HYPROMELLOSE 2910 (5 MPA.S)
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOL 400
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70010-293 | 70010-293-14, 70010-293-10, 70010-293-56, 70010-293-79 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIB |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-07-14 | daily-update | 2026-07-18 05:10:09 |
| 1 | 2026-07-09 | daily-update | 2026-07-17 21:45:24 |
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 |
|---|---|---|---|---|---|---|---|
| A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-12-22 |
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 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209274-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2017-12-22 | 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 |
|---|---|---|---|---|---|---|
| Cetirizine hydrochloride - HIVES | CETIRIZINE HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 562b5e6c-6103-df3d-e063-6394a90a897d | 2026-07-14 | Warnings | 70010-293-56 70010-293-14 70010-293-79 70010-293-10 70010-293 70010029314 70010029356 70010029310 70010029379 562b5e6c-6103-df3d-e063-6394a90a897d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.