Indications and uses
for relief of occasional sleeplessness
for relief of occasional sleeplessness
adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age: do not use
Diphenhydramine HCl 25mg
Nighttime Sleep aid
for relief of occasional sleeplessness
you are taking sedatives or tranquilizers
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose Warning: 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: take 2 caplets at bedtime if needed or as directed by a doctor
children under 12 years of age: do not use
croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
SOUNDBODY™
Compare to the Active Ingredients in Simply Sleep®*
For Nighttime Use
Sleep Aid
Diphenhydramine HCl 25 mg
24 Caplets
(pill image) Actual Size
Distributed by: Allegiant Health
Deer Park, NY 11729
V#5003620 ITEM#FP064
LB1307
R0617
Questions or Comments?
1-888-952-0050

| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69168-910-93 | 2020-12-03 | C162847 | 48780-1 | 9d75b9d0-b656-f424-e053-dadaa90a57ce | SoundBody Sleep Aid |
| 69168-910-93 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b656-f424-e053-dadaa90a57ce | SoundBody Sleep Aid |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69168-910 | 69168-910-93 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| HYPROMELLOSES | 3NXW29V3WO | 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 |
|---|---|---|---|---|---|---|
| 78c523df-c041-468a-bffc-25fa2a9fb5c1 | 4ddcf701-ce91-4d44-bee7-66e382691ccc | 2017-11-15 | Warnings | 78c523df-c041-468a-bffc-25fa2a9fb5c1 4ddcf701-ce91-4d44-bee7-66e382691ccc |
Adverse event summaries are temporarily unavailable. Other product information remains available.