Acetaminophen, Diphenhydramine HCl Tablets

Manufacturer
Velocity Pharma
Effective date
2018-05-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:33

Label at a glance#

ProductPain Relief PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

do not exceed recommended dose Adults and children 12 years and over: take 2 caplets at bedtime. do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

OTC - PURPOSE SECTION

pain reliever/fever reducer

Nighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

  • temporarily 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 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product
  • Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of 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.

do not use

  • with any other drug containing acetaminophen (prescription or not prescription). 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
  • With other products containing diphenhydramine, even one used on skin.

ask a doctor before use if you have

  • liver disease
  • asthma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • galucoma

ask your doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedative or tranquilizers.

When using this product

  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery, this product will cause drowsiness

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 lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dose
  • Adults and children 12 years and over:
  • take 2 caplets at bedtime.
  • do not take more than 2 caplets of this product in 24 hours.

    children under 12 years:

  • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information

SPL UNCLASSIFIED SECTION

  • store at 25 °C (77°F) excursions permitted between 15-30°C(59-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

this product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol PM

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,  pregelatinized starch, purified water, Sodium metabisulfite, Sodium starch glycolate, stearic acid, Titanium Dioxide, Talc

Questions or Comments

OTC - QUESTIONS SECTION

Call toll free 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 76168-119-25   50 COUNT

PM 50ctPM 50ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN2
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD2
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-119-25Pain Relief PM50 in 1 BOTTLETABLET502
76168-119-25Pain Relief PM1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-119PAIN RELIEF PM (ACETAMINOPHEN PM) TABLET [VELOCITY PHARMA]2Current NDC, Legacy NDC, 2 package rows20180515_c1c1de91-6a54-4d91-93a9-b6be6d7c7dfb.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76168-11976168-119-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML · Source PDF

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 PMVelocity Pharmac1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2018-05-14WarningsExact identifier
ndc (package): 76168-119-25
ndc (product): 76168-119
ndc11 (package): 76168011925
spl id: 6c30260f-b9e7-58c3-e053-2991aa0a818c
spl set id: c1c1de91-6a54-4d91-93a9-b6be6d7c7dfb

Reported adverse events (FAERS/openFDA)#

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