Dosage and administration
adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use
adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use
• each caplet contains: calcium 15 mg • store at 20-25 ° C (68-77 ° F). Avoid high humidity. Protect from light. • do not use if blister unit is broken or torn
Diphenhydramine HCl 25 mg
Nighttime sleep-aid
for relief of occasional sleeplessness
taking sedatives or tranquilizers
ask a health professional before use.
Overdose warning: 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 | take 2 caplets at bedtime if needed, or as directed by a doctor |
children under 12 years | do not use |
carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide
1-800-719-9260
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 24385-431-26 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1036-111a-e063-dadaa90a10e2 | Amerisource Bergen Nighttime Sleep Aid Drug Facts |
| 24385-431-78 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1036-111a-e063-dadaa90a10e2 | Amerisource Bergen Nighttime Sleep Aid Drug Facts |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24385-431-26 | EA - Each | 24385-431 | f9e5132e-d155-4945-928f-897b3756ef60 | 1 | 2012-07-24 |
| 24385-431-78 | EA - Each | 24385-431 | b27d50c7-0693-4dca-9796-d76fc0044454 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | ACTIVE INGREDIENT | TC2D6JAD40 | 2 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 24385-431 | 24385-431-26, 24385-431-78 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | POWDER, FOR SUSPENSION / ORAL | 396 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / ORAL | 907 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / AURICULAR (OTIC) | 0.02 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SPRAY / NASAL | 0.01 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, EXTENDED RELEASE / ORAL | 10 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, LIQUID FILLED / ORAL | 24 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CREAM / VAGINAL | 0.4 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRA-ARTICULAR | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CONCENTRATE / INTRAVENOUS | 4680 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | PASTE, DENTIFRICE / DENTAL | 51 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, DELAYED RELEASE / ORAL | 2834 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | CAPSULE, EXTENDED RELEASE / ORAL | 51 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / OPHTHALMIC | 26 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / TOPICAL | 34050 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION / INTRAMUSCULAR | 5 %w/v | ||
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 258.45 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg |
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 |
|---|---|---|---|---|---|---|
| 4c823908-d546-4a09-aacb-f95755dcd0b4 | e1704ac0-4507-4a64-b472-c936ee807ea1 | 2024-07-17 | Warnings | e1704ac0-4507-4a64-b472-c936ee807ea1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.