PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hcl tablet 
Kmart Corporation

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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Smart Sense 44-556-Delisted

Active ingredients (in each gelcap)

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

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
  • liver disease

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.

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

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

Questions or comments?

1-800-842-7886

Principal Display Panel

smart
sense®

NDC 49738-655-31

*COMPARE TO THE
ACTIVE INGREDIENTS IN
EXTRA STRENGTH TYLENOL® PM

EXTRA STRENGTH
pain relief PM

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

PAIN RELIEVER / NIGHTTIME SLEEP AID

ACTUAL SIZE

RAPID
RELEASE

80
GELCAPS

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 Extra
Strength Tylenol® PM.           50844       ORG061555631

Distributed by:
Kmart Corporation
Hoffman Estates,
IL 60179
Shop kmart.com

SATISFACTION
GUARANTEE

If you are unsatisfied for any
reason, return the unused portion
to the store for a full refund or
call 1-800-842-7886.

Smart Sense 44-556

Smart Sense 44-556

PAIN RELIEF PM  EXTRA STRENGTH
acetaminophen and diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-655
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
AMMONIA (UNII: 5138Q19F1X)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorBLUE (dark blue) , BLUE (light blue) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code L;6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-655-311 in 1 CARTON12/17/200704/23/2021
180 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49738-655-091 in 1 CARTON12/17/200704/23/2021
220 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/17/200704/23/2021
Labeler - Kmart Corporation (008965873)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(49738-655)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088MANUFACTURE(49738-655) , PACK(49738-655)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(49738-655)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(49738-655)

Revised: 7/2018
Document Id: d3c12c84-cf5f-4c99-9edc-e779a0824515
Set id: 792483e2-1e42-4ea6-8ee9-af059e6ccf69
Version: 11
Effective Time: 20180726
 
Kmart Corporation