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Pain Reliever Extra Strength by Chain Drug Consortium

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg
Labeler: Chain Drug Consortium
NDC Code: 68016-636

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.

Premier Value 44-531A

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
  • backache
  • muscular aches
  • headache
  • the common cold
  • toothache
  • minor pain of arthritis
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 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:

  • blisters
  • rash
  • skin reddening

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

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

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor

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

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Premier
Value®

NDC 68016-636-10

*COMPARE TO THE ACTIVE INGREDIENT IN
EXTRA STRENGTH TYLENOL®

Extra Strength
Pain Reliever
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER

100 Tablets

Non aspirin
Easy to swallow

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

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
www.emersongroup.com

*This product is not manufactured or
distributed by McNeil Consumer Healthcare,
owner of the registered trademark Extra
Strength Tylenol®.  50844    REV0816A53112

PV
Independently Tested
Satisfaction Guaranteed

If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.

Premier Value 44-531A

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-636
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
POVIDONE, UNSPECIFIED 
STEARIC ACID 
SUCRALOSE 
TITANIUM DIOXIDE 
D&C YELLOW NO. 10 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
TALC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;531
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-636-101 BOTTLE in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE
2NDC:68016-636-501 BOTTLE in 1 CARTON
250 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/11/2005
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(68016-636)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(68016-636)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(68016-636)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(68016-636)

 
Chain Drug Consortium

← See all Pain Reliever Extra Strength brands

Medically reviewed on May 21, 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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