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Pain Relief PM by CVS Pharmacy

Medically reviewed on March 13, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: CVS Pharmacy
NDC Code: 59779-373

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.

CVS 44-373

Active ingredients (in each tablet)

Acetaminophen 500 mg
Diphenhydramine citrate 38 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

for the 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 2 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product 

Do not use
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin 

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland 

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 may occur
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or opening machinery 

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • painful area is red or swollen

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 (1-800-222-1222) 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 of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor
  • children under 12 years: do not use 

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS Health

Compare to the active
ingredients in Excedrin® PM*

Coated Tablets

NDC 59779-373-12

Aspirin Free
PAIN RELIEF PM
ACETAMINOPHEN, 500 mg
DIPHENHYDRAMINE CITRATE, 38 mg

Pain reliever, Nighttime sleep-aid

• Non-habit forming
• For pain with sleeplessness

100 COATED TABLETS

Actual Size

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

*This product is not manufactured or distributed by Novartis Consumer
Health, Inc., owner of the registered trademark Excedrin® PM.
50844       ORG041437312

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©
2015 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
V-11112

CVS Quality
Money Back Guarantee

CVS 44-373


PAIN RELIEF PM 
acetaminophen and diphenhydramine citrate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-373
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE38 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
TITANIUM DIOXIDE 
STARCH, CORN 
CROSPOVIDONE, UNSPECIFIED 
SHELLAC 
SILICON DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;373
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-373-121 BOTTLE, PLASTIC in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/07/200402/17/2020
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-373)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-373)

 
CVS Pharmacy

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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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