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Pain Relief PM Extra Strength by CVS Pharmacy

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: CVS Pharmacy
NDC Code: 59779-235

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 44-235

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use
  • with any other product containing diphenhydramine, even one used on skin

  • in children under 12 years of age

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • 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

  • difficulty in urination due to enlargement of the 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
  • avoid alcoholic beverages

  • do not drive a motor vehicle or operate machinery

  • drowsiness will occur

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 more than 10 days

  • fever gets worse or lasts 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

♥︎CVSHealth™                                       Compare to the active ingredients
                                                               in Extra Strength Tylenol® PM*

Caplets

NDC 59779-235-08

EXTRA STRENGTH
Pain Relief PM   
ACETAMINOPHEN,
500 mg
DIPHENHYDRAMINE HCl, 25 mg
Pain reliever, Nighttime sleep aid

24 CAPLETS            Actual Size

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

*This product is not manufactured for distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.
50844          ORG061523508

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 44-235

PAIN RELIEF PM  EXTRA STRENGTH
acetaminophen and diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-235
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
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;235
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-235-081 BOTTLE in 1 CARTON
124 TABLET, FILM COATED in 1 BOTTLE
2NDC:59779-235-151 BOTTLE in 1 CARTON
250 TABLET, FILM COATED in 1 BOTTLE
3NDC:59779-235-121 BOTTLE in 1 CARTON
3100 TABLET, FILM COATED in 1 BOTTLE
4NDC:59779-235-29150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/15/1994
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-235)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(59779-235), PACK(59779-235)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(59779-235)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(59779-235)

 
CVS Pharmacy

← See all Pain Relief PM Extra Strength brands

Medically reviewed on Oct 26, 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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