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
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) contains: Sod...
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
10-1043 Rev. 04/18
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| diphenhydramine hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 14 | |
| diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 14 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | 14 | |
| D&C red no. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 14 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 14 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 14 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 14 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 14 | |
| saccharin sodium dihydrate | INACTIVE INGREDIENT | SB8ZUX40TY | 14 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 14 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 14 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 14 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54838-135 | 54838-135-40, 54838-135-70, 54838-135-80 |
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 | 1Q73Q2JULR | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| D&C red no. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SOLUTION / ORAL | 2 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / TOPICAL | 216 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| sorbitol | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 12 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION, SOLUTION / SUBCUTANEOUS | 4.7 %w/v | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | ELIXIR / ORAL | 15 mg/5ml | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SUBCUTANEOUS | 2 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION/ DROPS / AURICULAR (OTIC) | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / ORAL | 43 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAMUSCULAR | 0.13 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| D&C red no. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | PASTE / ORAL | 26 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / DENTAL | 0.3 %w/w | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / OPHTHALMIC | 0.02 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | GEL / TOPICAL | 4 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | LOTION / TOPICAL | 211 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | DROPS / AURICULAR (OTIC) | NA | ||
| D&C red no. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SUSPENSION / ORAL | 0.13 mg/5ml | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / SUBCUTANEOUS | 25 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SHAMPOO / TOPICAL | 0.07 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY, METERED / NASAL | 1.2 mg/1ml | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | AEROSOL, FOAM / TOPICAL | 0.04 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| saccharin sodium dihydrate | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| D&C red no. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SHAMPOO / TOPICAL | NA |
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 |
|---|---|---|---|---|---|---|
| cb6d2fa4-3d1a-4c5d-96f7-bf562c7c833b | 1cee4078-fe92-4af2-a2dd-bde4e9ccdfbd | 2018-04-23 | Warnings | cb6d2fa4-3d1a-4c5d-96f7-bf562c7c833b 1cee4078-fe92-4af2-a2dd-bde4e9ccdfbd |
Adverse event summaries are temporarily unavailable. Other product information remains available.