FDA.reportPublic FDA data

Genexa Acetaminophen PM

Manufacturer
Genexa Inc.
Effective date
2025-02-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:56:14

Label at a glance#

ProductGenexa Acetaminophen PM Extra Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever

Nighttime sleep aid

INDICATIONS & USAGE SECTION

Uses

temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4,000 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.

OTC - DO NOT USE SECTION

Do not use

  • 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 the skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

OTC - STOP USE SECTION

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

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

• do not take more than directed (see Overdose warning)

adults and children 12 years and over
  • take 2 caplets at bedtime if needed
  • do not take more than 2 caplets in 24 hours, unless directed by a doctor
children under 12 yearsask a doctor

OTHER SAFETY INFORMATION

Other information

  • each caplet contains: calcium 12 mg
  • store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

acacia gum‡, agave fiber‡, agave syrup‡, calcium carbonate‡, organic carnauba wax, cellulose‡, dextrose‡, dibehenin (vegetable source)‡, glycerin‡, guar gum‡, maltodextrin‡, organic palm olein, rice extract‡, rice hulls‡, sodium bicarbonate‡, organic sunflower lecithin, sunflower oil‡

‡natural

OTC - QUESTIONS SECTION

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing.

*This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Tylenol® PM Extra Strength Caplets.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30318 | genexa.com

Made in the USA with globally sourced ingredients

NDC 69676-0063-2

RECENT MAJOR CHANGES SECTION

Directions

• do not take more than directed (see Overdose warning)

adults and children 12 years and over
  • take 2 caplets at bedtime if needed
  • do not take more than 2 caplets in 24 hours, unless directed by a doctor
children under 12 years ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa®

MEDICINE MADE CLEAN

For Adults

Acetaminophen PM Extra Strength

with Diphenhydramine HCl

Pain Reliever Nighttime Sleep Aid

Compare to active ingredients in Tylenol® PM Extra Strength Caplets*

100 Caplets

Non-habit forming

How we're different

Made without: crospovidone, polyethylene glycol, titanium dioxide & more!

Adult APAP PM_Carton_R-20220323Adult APAP PM_Carton_R-20220323

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN5
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD5
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY5

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0063-22025-02-26C16284748780-12cef2736-b2c6-d83d-e063-dadaa90ab31fAcetaminophen PM Extra Strength Caplets
69676-0063-52025-02-26C16284748780-12cef2736-b2c6-d83d-e063-dadaa90ab31fAcetaminophen PM Extra Strength Caplets
69676-0063-22025-01-30C16284748780-12cef2736-b2c6-d83d-e063-dadaa90ab31fAcetaminophen PM Extra Strength Caplets
69676-0063-52025-01-30C16284748780-12cef2736-b2c6-d83d-e063-dadaa90ab31fAcetaminophen PM Extra Strength Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0063-2Genexa Acetaminophen PMExtra Strength100 in 1 BOTTLETABLET, COATED1005
69676-0063-2Genexa Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, COATED15
69676-0063-5Genexa Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, COATED15
69676-0063-5Genexa Acetaminophen PMExtra Strength50 in 1 BOTTLETABLET, COATED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0063GENEXA ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [GENEXA INC.]5Current NDC, Legacy NDC, 4 package rows20250228_d82cf6f3-a291-ca2b-e053-2a95a90a6de1.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-006369676-0063-2, 69676-0063-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
RICE BRANR60QEP13ICIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
POWDERED CELLULOSESMD1X3XO9MIACT
INULINJOS53KRJ01IACT
PALM OIL5QUO05548ZIACT
ACACIA5C5403N26OIACT
AGAVE TEQUILANA JUICEGVG8G0207OIACT
CARNAUBA WAXR12CBM0EIZIACT
DEXTROSEIY9XDZ35W2IACT
GUAR GUME89I1637KEIACT
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM BICARBONATE8MDF5V39QOIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
SUNFLOWER OIL3W1JG795YIIACT
GLYCERINPDC6A3C0OXIACT

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
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
ndc (package): 69676-0063-5
ndc (package): 69676-0063-2
ndc (product): 69676-0063
ndc11 (package): 69676006305
ndc11 (package): 69676006302
spl id: 2e9472c4-b466-e4fd-e063-6394a90ad2f6
spl set id: d82cf6f3-a291-ca2b-e053-2a95a90a6de1

Reported adverse events (FAERS/openFDA)#

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