Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 caplets at bedtime ■ do not take more than 2 caplets in 24 hours unless directed by a doctor ■ children under 12 years do not use
Acetaminophen 500 mg
Diphenhydramine 25 mg
Acetaminophen 500 mg ....................................................................................................................................Pain reliever
Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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.
■ with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist ■ with any other product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ if you have ever had an allergic reaction to this product or any of its ingredients.
■ liver disease
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland.
■ drowsiness will occur
■ avoid alcoholic drinks
■ do not drive a motor vehicle or operate machinery.
■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur. These could be signs of a serious condition.
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN
Overdose warning: In case of overdose, get medical help or contact Poison Control (1-800-222-1222) right away.
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ do not take more than directed (see overdose warning) adults and children 12 years and over
■ take 2 caplets at bedtime
■ do not take more than 2 caplets in 24 hours unless directed by a doctor
■ children under 12 years do not use
FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.
Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit
www.pioneerlifesciences.com
This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare
Division., owner of the registered trademark Tylenol® Extra Strength Tablets.
Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | X002OT0E5H | PL0035-Rev 01 Pain Relief PM- 375ct - Elysium 08.02.2023_page-0001.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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72090-006-25 | 2024-05-08 | C162847 | 48780-1 | f386c649-a227-0266-e053-dadaa90a7c1a | Pain Relief PM |
| 72090-006-25 | 2024-05-08 | C162847 | 48780-1 | f386c649-a227-0266-e053-dadaa90a7c1a | Pain Relief PM |
| 72090-006-25 | 2023-01-30 | C162847 | 48780-1 | f386c649-a227-0266-e053-dadaa90a7c1a | Pain Relief PM |
| 72090-006-25 | 2023-01-30 | C162847 | 48780-1 | f386c649-a227-0266-e053-dadaa90a7c1a | Pain Relief PM |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72090-006 | 72090-006-25 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2025-12-29 | full-release | 2026-06-01 01:29:24 |
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 |
|---|---|---|---|---|---|---|
| 99b7581b-b3ad-4191-8245-665177a21686 | ad29a37f-39a2-5c84-e053-2995a90a2f39 | 2025-12-29 | Warnings | ad29a37f-39a2-5c84-e053-2995a90a2f39 |
Adverse event summaries are temporarily unavailable. Other product information remains available.