TYLENOL PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride solution 
Johnson & Johnson Consumer Inc.

----------

TYLENOL PM

Extra Strength

Drug Facts

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

Uses

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.

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 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

  • 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

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

When using this product

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

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.

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

Keep out of reach of children.

Overdose warning

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

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

Inactive ingredients

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?

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

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
TYLENOL PM  EXTRA STRENGTH
acetaminophen and diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-833
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Colorblue (Dark Blue) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-833-01240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/25/2018
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024
Document Id: 0f877554-af31-eaaf-e063-6294a90af3a9
Set id: 44e8a92a-748b-4dc3-ae8d-176a350ac83d
Version: 4
Effective Time: 20240122
 
Johnson & Johnson Consumer Inc.