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Pain Reliever PM Extra Strength

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Walgreens
NDC Code: 0363-0213

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 caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

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

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 a serious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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: In case of overdose, get medical help or contact a Poison Control Center right away. 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 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
  • children under 12 years: do not use

Other information
  • store at room temperature 15°-30°C (59°-86°F)
  • avoid high humidity and excessive heat

Inactive ingredients

croscarmellose sodium*, D&C yellow #10 aluminum lake*, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake*, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, titanium dioxide, triacetin*

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

EXTRA STRENGTH

Pain Reliever PM

Acetaminophen 500 mg / Pain Reliever

Diphenhydramine HCl 25 mg / Nighttime Sleep Aid

NIGHTTIME

CAPLETS

Compare to Tylenol® PM Extra Strength Caplets active ingredients≠≠

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

≠≠This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® PM Extra Strength Caplets.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

Package Label

Well at Walgreens Extra Strength Pain Reliever PM Caplets

 

PAIN RELIEVER PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0213
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
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
D&C YELLOW NO. 10 
MAGNESIUM SILICATE 
MINERAL OIL 
STARCH, CORN 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
TRIACETIN 
ALUMINUM OXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeS525;CPC752
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0213-501 BOTTLE, PLASTIC in 1 BOX
150 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:0363-0213-101 BOTTLE, PLASTIC in 1 BOX
2100 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:0363-0213-151 BOTTLE, PLASTIC in 1 BOX
3150 TABLET, COATED in 1 BOTTLE, PLASTIC
4NDC:0363-0213-241 BOTTLE, PLASTIC in 1 BOX
424 TABLET, COATED in 1 BOTTLE, PLASTIC
5NDC:0363-0213-25250 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/31/2013
Labeler - Walgreens (008965063)
Registrant - P and L Development of New York Corporation (800014821)

 
Walgreens

← See all Pain Reliever PM Extra Strength brands

Medically reviewed on Jul 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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