OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 500mg; Diphenhydramine 25mg
Acetaminophen 500mg; Diphenhydramine 25mg
colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
| adults and children 12 years of age and over |
|
| children under 12 years of age | do not use |
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
if a skin reaction occurs, stop use and seek medical help right away
Do not use
Ask a doctor before use if you have
Ask a doctor or a pharmacist before use if you are
When using this product
Stop use and ask a doctor if
These could be signs of a serious condition
If pregnant or breast-feeding,
ask a health professional before use
Keep out of reach of children
Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children
Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Pain reliever
Nighttime sleep-aid
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70692-119-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9850-a426-e053-dadaa90af4c2 | Pain Relief PM - Extra Strength Body Pain - Dolor Corporal (Acetaminophen 500mg; Diphenhydramine Hydrochloride 25mg) |
| 70692-119-41 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9850-a426-e053-dadaa90af4c2 | Pain Relief PM - Extra Strength Body Pain - Dolor Corporal (Acetaminophen 500mg; Diphenhydramine Hydrochloride 25mg) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70692-119-05 | Acetaminophen 500mg Diphenhydramine HCl 25mg | 50 in 1 PACKAGE | TABLET | 50 | 3 | |
| 70692-119-41 | Acetaminophen 500mg Diphenhydramine HCl 25mg | 4 in 1 PACKAGE | TABLET | 4 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70692-119 | 70692-119-41, 70692-119-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| b43d776e-b5f4-16b9-e053-2995a90a66b9 | 9238598b-1202-921f-e053-2995a90a019f | 2020-11-16 | Warnings | b43d776e-b5f4-16b9-e053-2995a90a66b9 9238598b-1202-921f-e053-2995a90a019f |
Adverse event summaries are temporarily unavailable. Other product information remains available.