PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet, coated 
CVS Pharmacy

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.

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DRUG FACTS

Active ingredients (in each geltab)

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:

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 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.

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 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours.
  • children under 12 years: do not use

Other information

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

Inactive ingredients

corn starch*, croscarmellose sodium*, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose*, maltodextrin*, microcrystalline cellulose*, polyethylene glycol*, povidone*, purified water, silicon dioxide*, stearic acid, titanium dioxide
*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

Compare to the active ingredients in extra strength TYLENOL® PM **

extra strength

PAIN RELIEF PM

GELTABS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

pain reliever/ nighttime sleep-aid

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

Non-habit forming

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Product Label

CVS Pharmacy

Pain Relief PM Geltabs

PAIN RELIEF PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-360
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
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
HYPROMELLOSES 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
WATER 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
Product Characteristics
ColorBLUE, WHITEScoreno score
ShapeOVALSize13mm
FlavorImprint Code BPI50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-360-151 in 1 BOX
1150 in 1 BOTTLE
2NDC:59779-360-241 in 1 BOX
224 in 1 BOTTLE
3NDC:59779-360-501 in 1 BOX
350 in 1 BOTTLE
4NDC:59779-360-101 in 1 BOX
4100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/08/2010
Labeler - CVS Pharmacy (062312574)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 902199d4-b806-4727-9953-a86466df4b30
Set id: ec36bd16-5e43-4dac-bbd7-76e00f187c44
Version: 2
Effective Time: 20121220
 
CVS Pharmacy