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Tylenol PM Extra Strength by McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Dosage form: tablet, coated
Ingredients: Acetaminophen 500mg, Diphenhydramine Hydrochloride 25mg
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
NDC Code: 50580-176

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.

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

  • 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 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 #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

NDC 50580-176-10

See New Warnings Information & Directions

Extra Strength
TYLENOL®
PM

Non-habit forming

Pain Reliever
Nighttime Sleep Aid
Acetaminophen,
Diphenhydramine HCl

100 GELTABS

Geltabs*
* Gelatin-Coated Tablets

TYLENOL PM   EXTRA STRENGTH
acetaminophen and diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem 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 
butylparaben 
castor oil 
D&C red No. 28 
edetate calcium disodium 
FD&C blue No. 1 
gelatin 
hypromelloses 
magnesium stearate 
methylparaben 
powdered cellulose 
propylene glycol 
propylparaben 
shellac 
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
ShapeROUNDSize11mm
FlavorImprint CodeTYLENOL;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-176-101 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1100 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
2NDC:50580-176-121 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
2120 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
3NDC:50580-176-151 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
3150 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
4NDC:50580-176-181 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
418 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
5NDC:50580-176-191 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
5190 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
6NDC:50580-176-241 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
624 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
7NDC:50580-176-401 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
740 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
8NDC:50580-176-501 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
850 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
9NDC:50580-176-651 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
965 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
10NDC:50580-176-701 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1070 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33812/01/1991
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 04/2011
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

← See all Tylenol PM Extra Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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