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

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.

Directions

do not take more than directed (see overdose warning)

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

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 with "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 #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

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: 04/2010McNeil Consumer Healthcare Div McNeil-PPC, Inc