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
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| 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 | 2023-01-30 | C162847 | 48780-1 | f386c649-a227-0266-e053-dadaa90a7c1a | Pain Relief PM |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72090-006-25 | Pain Relief PM | 375 in 1 BOTTLE | TABLET | 375 | 4 |
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.
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 |
|---|---|---|---|---|---|---|
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE | Pioneer Life Sciences, LLC | ad29a37f-39a2-5c84-e053-2995a90a2f39 | 2025-12-29 | Warnings | 72090-006-25 72090-006 72090000625 99b7581b-b3ad-4191-8245-665177a21686 ad29a37f-39a2-5c84-e053-2995a90a2f39 |
Adverse event summaries are temporarily unavailable. Other product information remains available.