Indications and uses
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • o runny nose o sneezing o itchy, watery eyes o itching of the nose or throat
• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • o runny nose o sneezing o itchy, watery eyes o itching of the nose or throat
• repeat dose every 4 to 6 hours • do not take more than 6 doses in any 24-hour period • Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. adults and children 12 years and over 2 to 4 teaspoonfuls (TSP) children 6 to under 12 years 1 to 2 teaspoonfuls (TSP) children under 6 years DO NOT USE Other information Each 5 mL (1 TSP) contain...
Active Ingredient: Diphenhydramine HCl 12.5 mg (in each 5 mL (teaspoonful)(TSP))
Purpose: Antihistamine
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
If pregnant or breast-feeding, 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).
adults and children 12 years and over | 2 to 4 teaspoonfuls (TSP) |
children 6 to under 12 years | 1 to 2 teaspoonfuls (TSP) |
children under 6 years | DO NOT USE |
Other information
Each 5 mL (1 TSP) contains: Sodium 14 mg. Store at room temperature 20°-25°C (68°-77°F).
citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, water.
Questions
1-844-834-0530
Manufactured by:
Silarx Pharmaceuticals, Inc.
Carmel, NY 10512
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
10-1043 Rev. 04/18
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71205-410-04 | ML - Milliliter | 71205-410 | 63533993-ea29-44e0-8373-29e3c24e0378 | 1 | 2020-04-20 |
| 54838-135-40 | ML - Milliliter | 54838-135 | 87d16fcc-e01c-4b61-ae11-a13ea6bb9056 | 1 | 2012-07-24 |
| 54838-135-70 | ML - Milliliter | 54838-135 | f13f7b19-421d-47eb-a27f-5cdbb6c15d26 | 1 | 2012-07-24 |
| 54838-135-80 | ML - Milliliter | 54838-135 | 4a60ef46-6956-40fc-bc99-ce529980ed8c | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71205-410 | 71205-410-04 |
| 54838-135 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | 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 |
|---|---|---|---|---|---|---|
| 36009623-fffe-4511-83df-cb513818d0e6 | c4a35a3e-253a-4815-964a-892d17832252 | 2024-01-01 | Warnings | 36009623-fffe-4511-83df-cb513818d0e6 c4a35a3e-253a-4815-964a-892d17832252 |
Adverse event summaries are temporarily unavailable. Other product information remains available.