Indications and uses
• for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep
• for the relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep
• take only one dose per day (24 hours) • only use dose cup provided adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor children under 12 yrs do not use • each 30 mL dose cup contains: sodium 20 mg • store at 20-25˚C (68-77˚F)
Diphenhydramine HCl 50 mg
Nighttime sleep-aid
taking sedatives or tranquilizers
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
adults & children 12 yrs & over | 30 mL at bed time if needed or as directed by a doctor |
children under 12 yrs | do not use |
alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate
1-800-719-9260
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 1 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50594-008 | 50594-008-40 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | 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 |
|---|---|---|---|---|---|---|
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | INJECTION / INTRAVENOUS | 22 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| HIGH FRUCTOSE CORN SYRUP | HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | SOLUTION / ORAL | 10000 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CAPSULE / ORAL | 8.5 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | GEL / TOPICAL | 28 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / RECTAL | 290 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / ORAL | 84 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / RECTAL | 904 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / NASAL | 5 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE / ORAL | 131 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 35 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | FILM / BUCCAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAMUSCULAR | 864 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 48 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | POWDER, FOR SUSPENSION / ORAL | 570 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SYRUP / ORAL | 268 mg | ||
| POLOXAMER 407 | POLOXAMER 407 | TUF2IVW3M2 | SUSPENSION / ORAL | 10 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | CONCENTRATE / ORAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SOLUTION / ORAL | 98 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / TOPICAL | 5 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v |
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 |
|---|---|---|---|---|---|---|
| d8f0d0a4-b537-4562-8061-611c6e8de706 | dc5e173a-7c8e-4de5-9400-bcdd8ea7b9ef | 2024-11-05 | Warnings | dc5e173a-7c8e-4de5-9400-bcdd8ea7b9ef |
Adverse event summaries are temporarily unavailable. Other product information remains available.