TYLENOL® PM

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

----------

TYLENOL®
PM

Drug Facts

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

Uses

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

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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.

Directions

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

Inactive ingredients

benzyl alcohol, butylparaben, castor oil, D&C red #28, edetate calcium disodium, FD&C blue #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

PRINCIPAL DISPLAY PANEL

See New Warnings Information & Directions

NDC 50580-176-50
Extra Strength

TYLENOL®
PM

Pain Reliever
Nighttime Sleep Aid
Acetaminophen,
Diphenhydramine HCl

50 GELTABS

Geltabs*
* Gelatin-Coated Tablets

Non-habit
forming

Principal Display Panel

TYLENOL PM   EXTRA STRENGTH
acetaminophen and diphenhydramine hydrochloride   tablet, coated
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)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
No Inactive Ingredients Found
Product Characteristics
ColorWHITE, BLUE (white and blue geltab printed TYLENOL PM in gray ink) Score no score
ShapeROUNDSize11mm
FlavorImprint Code TYLENOL;PM
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
150580-176-101 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
1100 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-10)
250580-176-121 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
2120 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-12)
350580-176-151 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
3150 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-15)
450580-176-241 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
424 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-24)
550580-176-501 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
550 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-50)
650580-176-701 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
670 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-70)
750580-176-401 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
740 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-40)
850580-176-191 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
8190 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-19)
950580-176-181 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
918 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-18)
1050580-176-651 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
1065 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-65)
1150580-176-061 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
116 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50580-176-06)
1250580-176-022 TABLET In 1 POUCHNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33812/01/1991

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
Revised: 04/2010McNeil Consumer Healthcare Div McNeil-PPC, Inc