FDA.reportPublic FDA data

TYLENOL PM

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2024-01-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:11:54

Label at a glance#

ProductTYLENOL PM Extra Strength
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 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 ) mL = milliliter use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 30 mL in the dosing cup provided at bedtime do not take more than 30 mL of this product in 24 hours children under 12 years do not use

Storage and handling

each 30 mL contains: sodium 15 mg store between 20-25°C (68-77°F) do not use if neck band imprinted with "TYLENOL PM" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each 30 mL)Purpose
Acetaminophen 1,000 mgPain reliever
Diphenhydramine HCl 50 mgNighttime sleep aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Ask a doctor or pharmacist 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.

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.

Overdose warning

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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)
  • mL = milliliter
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults and children 12 years and over
  • take 30 mL in the dosing cup provided at bedtime
  • do not take more than 30 mL of this product in 24 hours
children under 12 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 15 mg
  • store between 20-25°C (68-77°F)
  • do not use if neck band imprinted with "TYLENOL PM" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-833-01

Extra Strength
TYLENOL ®
PM

NEW

Acetaminophen Diphenhydramine HCl
Pain Reliever, Nighttime Sleep Aid
Non-habit forming

8 fl oz (240 mL)

Bedtime Berry

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-833-012024-02-01C16284748780-11030e365-36cc-111a-e063-dadaa90a10e2TYLENOL PM Extra Strength
50580-833-012024-01-30C16284748780-11030e365-36cc-111a-e063-dadaa90a10e2TYLENOL PM Extra Strength

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-833-01ML - Milliliter50580-8334eb50548-bfd6-4ca0-8b96-8e53a76d98be12018-10-11

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-83350580-833-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
24bef0ec-3b8a-c319-e063-6394a90af4c644e8a92a-748b-4dc3-ae8d-176a350ac83d2024-10-18WarningsExact identifier
spl set id: 44e8a92a-748b-4dc3-ae8d-176a350ac83d

Reported adverse events (FAERS/openFDA)#

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