EXTRA STRENGTH NON-ASPIRIN PM - acetaminophen and diphenhydramine hydrochloride tablet, film coated 
Rite Aid

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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Active ingredients

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

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

  • in children under 12 years of age

Ask a doctor before use if

  • a breathing problem such as emphysema or chronic bronchitis

  • liver disease

  • 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 beverages

  • 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 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: 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.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

RITE AID® PHARMACY

*COMPARE TO THE ACTIVE INGREDIENTS IN TYLENOL® PM CAPLETS

TAMPER EVIDENT BOTTLE

EXTRA STRENGTH

PAIN RELIEVER/SLEEP AID

Acetaminophen PM

Diphenhydramine HCl 25 mg

Acetaminophen 500 mg

For Pain with Sleeplessness

300 CAPLETS

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

50844    REV0410F23517

DISTRIBUTED BY:

Rite Aid Corporation

30 Hunter Lane, Camp Hill, PA 17011

Rite Aid 235-17


EXTRA STRENGTH NON-ASPIRIN PM 
acetaminophen and diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0235
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
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POLYVINYL ALCOHOL 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScore no score
ShapeCAPSULESize17mm
FlavorImprint Code 44;235
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:11822-0235-51 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
150 TABLET, FILM COATED (50 TABLET) in 1 BOTTLE, PLASTICThis package is contained within the CARTON (11822-0235-5)
2NDC:11822-0235-11 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTONcontains a BOTTLE, PLASTIC
260 TABLET, FILM COATED (60 TABLET) in 1 BOTTLE, PLASTICThis package is contained within the CARTON (11822-0235-1)
3NDC:11822-0235-7300 TABLET, FILM COATED (300 TABLET) in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/15/1994

Labeler - Rite Aid (014578892)

Revised: 08/2011 Rite Aid