Pain Relief PM

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:24

Label at a glance#

ProductPain Relief PM
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure17 sections

Indications and uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and administration

■ 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

Label contents#

Full prescribing information#

Active Ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Diphenhydramine 25 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen 500 mg ....................................................................................................................................Pain reliever
Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid

Uses:

INDICATIONS & USAGE SECTION

  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings:

WARNINGS SECTION

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.

Do Not use

OTC - DO NOT USE SECTION

■ 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.

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

■ liver disease

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland.

Ask a doctor or pharmacist before use if you are 

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

■ drowsiness will occur

■ avoid alcoholic drinks

■ do not drive a motor vehicle or operate machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

■ 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

Other Information:

OTHER SAFETY INFORMATION

  • store at 20°-25°C (68°-77°F)
  • do not use if foil or inner seal is broken or missing

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0035-Rev 01 Pain Relief PM- 375ct - Elysium 08.02.2023_page-0001PL0035-Rev 01 Pain Relief PM- 375ct - Elysium 08.02.2023_page-0001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN4
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD4
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X002OT0E5HPL0035-Rev 01 Pain Relief PM- 375ct - Elysium 08.02.2023_page-0001.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72090-006-252024-05-08C16284748780-1f386c649-a227-0266-e053-dadaa90a7c1aPain Relief PM
72090-006-252023-01-30C16284748780-1f386c649-a227-0266-e053-dadaa90a7c1aPain Relief PM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-006-25Pain Relief PM375 in 1 BOTTLETABLET3754

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72090-00672090-006-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINEPioneer Life Sciences, LLCad29a37f-39a2-5c84-e053-2995a90a2f392025-12-29WarningsExact identifier
ndc (package): 72090-006-25
ndc (product): 72090-006
ndc11 (package): 72090000625
spl id: 99b7581b-b3ad-4191-8245-665177a21686
spl set id: ad29a37f-39a2-5c84-e053-2995a90a2f39

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.