Indications and uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
take every 4 to 6 hours, or as directed by a doctor adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours. children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. children under 6 years do not use
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from excessive moisture see end flap for expiration date and lot number
Chlorpheniramine maleate 4 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
to make a child sleepy.
taking sedatives or tranquilizers.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
| adults and children 12 years and over | 1 tablet. Do not exceed 6 tablets in 24 hours. |
| children 6 to under 12 years | 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. |
| children under 6 years | do not use |
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose
1-800-645-2158
Product: 50090-2000
NDC: 50090-2000-6 20 TABLET in a BOTTLE
NDC: 50090-2000-7 60 TABLET in a BOTTLE
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2000-6 | 2023-02-06 | C162847 | 48780-1 | f386c649-ab63-0266-e053-dadaa90a7c1a | Rugby 44-194 |
| 50090-2000-7 | 2023-02-06 | C162847 | 48780-1 | f386c649-ab63-0266-e053-dadaa90a7c1a | Rugby 44-194 |
| 50090-2000-6 | 2023-01-30 | C162847 | 48780-1 | f386c649-ab63-0266-e053-dadaa90a7c1a | Rugby 44-194 |
| 50090-2000-7 | 2023-01-30 | C162847 | 48780-1 | f386c649-ab63-0266-e053-dadaa90a7c1a | Rugby 44-194 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2000-7 | EA - Each | 50090-2000 | 3786a027-34f4-4108-b0b8-859317ac58e8 | 1 | 2021-09-07 |
| 0536-1006-01 | EA - Each | 0536-1006 | 270e3d12-6807-4d73-a4ac-8095b9e4ddd1 | 1 | 2015-01-05 |
| 0536-1006-10 | EA - Each | 0536-1006 | 408f78fc-0a2b-4ee6-bf90-2376920c8427 | 1 | 2014-10-03 |
| 0536-1006-35 | EA - Each | 0536-1006 | 12500282-7eed-43ac-ae9d-c106fee79878 | 1 | 2014-06-03 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-2000 | 50090-2000-6, 50090-2000-7 |
| 0536-1006 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| D&C YELLOW NO. 10 ALUMINUM LAKE | CQ3XH3DET6 | IACT |
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
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 |
|---|---|---|---|---|---|---|
| Aller-chlor | CHLORPHENIRAMINE MALEATE | Rugby Laboratories | 04ca3806-72be-47d4-9fea-5b0dee087683 | 2026-07-08 | Warnings | 0536-1006 |
| 8130cf94-48cd-4536-8408-7e3196a81087 | d2024ec2-4e15-4b51-9430-50b42b51bd73 | 2024-11-05 | Warnings | d2024ec2-4e15-4b51-9430-50b42b51bd73 |
Adverse event summaries are temporarily unavailable. Other product information remains available.