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
Indoor and Outdoor Allergy Relief
- Manufacturer
- Famora Inc.
- Effective date
- 2026-03-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:50:42
Label at a glance#
ProductIndoor and Outdoor Allergy Relief
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure9 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#
Drug Facts
Active ingredient (in each tablet)
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
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 sedatives or tranquilizers
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 (1-800-222-1222) right away.
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)
- do not use if pouch is torn or damaged
- meets USP Dissolution Test 2
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene
glycol, titanium dioxide
Questions or comments?
1-800-373-6981
SPL UNCLASSIFIED SECTION
Distributed by:
Famora Inc.
Elk Grove Village, IL 60007
PRINCIPAL DISPLAY PANEL
Allergy Relief
Cetirizine 10 mg
Label
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CETIRIZINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87509-0002-3 | Indoor and Outdoor Allergy Relief | 365 in 1 BOTTLE | TABLET, COATED | 365 | 1 |
Products#
Every source-derived product name is available through these pages.
- Indoor and Outdoor Allergy Relief
- Cetirizine HCl
- HYPROMELLOSES
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- STARCH, CORN
- POVIDONE
- POLYETHYLENE GLYCOL 400
- TITANIUM DIOXIDE
- CETIRIZINE HYDROCHLORIDE
- CETIRIZINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87509-0002 | 87509-0002-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CETIRIZINE HYDROCHLORIDE | 64O047KTOA | ACTIM |
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 |
|---|---|---|---|---|---|---|---|
| A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2009-08-26 | ||
| A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RS | 2009-08-26 | |
| A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2009-08-26 | ||
| A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2009-08-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | RS | 2009-08-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-003 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077829-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2009-08-26 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| Indoor and Outdoor Allergy Relief | CETIRIZINE HCL | Famora Inc. | 2a94d25c-aacf-4f5c-b406-815f0e1d0611 | 2026-03-18 | Warnings | 87509-0002-3 87509-0002 87509000203 4d50d76d-12e9-17c0-e063-6394a90a4f6f 2a94d25c-aacf-4f5c-b406-815f0e1d0611 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.