PAIN RELIEF- acetaminophen tablet, coated 
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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Kmart Corporation Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

•
the common cold
•
headache
•
backache
•
toothache
•
muscular aches
•
premenstrual and menstrual cramps
•
minor pain of arthritis
•
temporarily reduces fever

Warnings

Overdose warning: Taking more than the recommended dose can cause serious health problems, including 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.

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use

with any other product containing acetaminophen

Stop use and ask a doctor if

•
new symptoms occur
•
redness or swelling is present
•
pain gets worse or lasts for more than 10 days
•
fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

•
do not take more than directed (see overdose warning)
•
swallow whole – do not crush, chew or dissolve

adults and children

12 years and over
•
take 2 caplets every 6 hours as needed
•
do not take more than 8 caplets in 24 hours
•
do not use for more than 10 days unless directed by a doctor

children under 12 years

do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

•
store at 20º-25ºC (68º-77ºF)

Inactive ingredients

flavor, hypromellose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate*, starch, stearic acid, sucralose, titanium dioxide *may contain this ingredient

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO TYLENOL® EXTRA STRENGTH active ingredient

EXTRA STRENGTH

PAIN RELIEF

ACETAMINOPHEN

Pain Reliever/Fever Reducer

COOL ICE® CAPS

Easy to Swallow

Instant Cooling Sensation

500 mg

Pain Relief Carton Image 1

Pain Relief Carton Image 1

Pain Relief Carton Image 2

Pain Relief Carton Image 1

Pain Relief Carton Image 2

PAIN RELIEF 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (tablet) Size18mm
FlavorVANILLA (Menthol) Imprint Code L010
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-010-781 in 1 CARTON03/09/200505/11/2013
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/09/200505/11/2013
Labeler - Kmart Corporation (008965873)

Revised: 11/2017
Document Id: 957de9cc-fcc5-43e6-934d-cf6aa6106c9c
Set id: dfa9a9e0-9871-4a39-9336-f83ef7a72bce
Version: 2
Effective Time: 20171114
 
Kmart Corporation