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

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TYLENOL®
PM

Drug Facts

Active ingredients (in each geltab) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime 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 years do 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 Type HUMAN OTC DRUG NDC Product Code (Source) 50580-176
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 500 mg
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color WHITE, BLUE (white and blue geltab printed TYLENOL PM in gray ink) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code TYLENOL;PM
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 50580-176-10 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1 100 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-10)
2 50580-176-12 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
2 120 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-12)
3 50580-176-15 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
3 150 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-15)
4 50580-176-24 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
4 24 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-24)
5 50580-176-50 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
5 50 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-50)
6 50580-176-70 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
6 70 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-70)
7 50580-176-40 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
7 40 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-40)
8 50580-176-19 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
8 190 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-19)
9 50580-176-18 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
9 18 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-18)
10 50580-176-65 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
10 65 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-65)
11 50580-176-06 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
11 6 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-176-06)
12 50580-176-02 2 TABLET In 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part338 12/01/1991

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