TYLENOL PM  EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet, coated 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.



Drug Facts

Active ingredients (in each geltab)Purpose
Acetaminophen 500 mgPain reliever
Diphenhydramine HCl 25 mgNighttime sleep aid


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


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

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 before use 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

Taking more than the recommended dose (overdose) may cause liver damage. 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.


adults and children 12 years and over
  • take 2 geltabs at bedtime
  • do not take more than 2 geltabs of this product in 24 hours
children under 12 yearsdo 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

  • store between 20-25°C (68-77°F). Avoid high humidity.
  • do not use if carton is opened, or neck wrap or foil inner seal imprinted "SAFETY SEAL®" is broken or missing
  • see end panel for lot number and expiration date

Inactive ingredients

benzyl alcohol, butylparaben, castor oil, D&C red no. 28, edetate calcium disodium, FD&C blue no. 1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, shellac, simethicone, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide

Questions or comments?

call 1-877-895-3665



NDC 50580-176-10

See New Warnings Information & Directions

Extra Strength

Non-habit forming

Pain Reliever
Nighttime Sleep Aid
Diphenhydramine HCl


* Gelatin-Coated Tablets

acetaminophen and diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-176
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
castor oil 
D&C red No. 28 
edetate calcium disodium 
FD&C blue No. 1 
magnesium stearate 
powdered cellulose 
propylene glycol 
sodium citrate 
sodium lauryl sulfate 
sodium propionate 
sodium starch glycolate type A potato 
titanium dioxide 
Product Characteristics
ColorWHITE, BLUE (white and blue geltab printed TYLENOL PM in gray ink) Scoreno score
FlavorImprint Code TYLENOL;PM
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-176-101 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
2NDC:50580-176-121 in 1 CARTON
2120 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
3NDC:50580-176-151 in 1 CARTON
3150 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
4NDC:50580-176-181 in 1 CARTON
418 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
5NDC:50580-176-191 in 1 CARTON
5190 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
6NDC:50580-176-241 in 1 CARTON
624 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
7NDC:50580-176-401 in 1 CARTON
740 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
8NDC:50580-176-501 in 1 CARTON
850 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
9NDC:50580-176-651 in 1 CARTON
965 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
10NDC:50580-176-701 in 1 CARTON
1070 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/01/199110/25/2013
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 9/2014
McNeil Consumer Healthcare Div. McNeil-PPC, Inc