Indications and uses
Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Do not take more than directed. (see overdose warning) Adults and children 12 years of age and older: Take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours Children under 12 years: do not use
Acetaminophen 500mg
Diphenhydramine HCl 25mg
Pain reliever
Nightime sleep aid
Keep out of reach of children.In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Prompt Medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you take
• More than 4000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product.
Allergy Alert:Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters, rash. 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 pharmacist before use if you are:
When using this product:
•drowsiness will occur
•do not drive a motor vehicle or operate machinery
•avoid alcoholic drinks
Stop use and ask a doctor if:
•sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness
•pain gets worse or last for more than 10 days.
•fever gets worse or last for more than 3 days
•redness or swelling are present
•new symptoms occur. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Do not take more than directed. (see overdose warning)
Adults and children 12 years of age and older:Take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours
Children under 12 years:do not use
croscarmellose sodium, FD and C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0085317004903 | GTIN-13: 0085317004903 EAN-13: 0085317004903 GTIN-12: 085317004903 UPC-A: 085317004903 GTIN storage (14 digits): 00085317004903 | PMC50024 107-50.jpg |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51824-107-50 | CAREALL Pain Relief PMExtra Strength | 50 in 1 BOTTLE | TABLET | 50 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51824-107 | 51824-107-50 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| CAREALL Pain Relief PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | New World Imports, Inc | c93aa5e4-3994-439f-8f14-4e81773ed4e2 | 2025-12-22 | Warnings | 51824-107-50 51824-107 51824010750 46905264-466d-6fd8-e063-6394a90ae817 c93aa5e4-3994-439f-8f14-4e81773ed4e2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.