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Pain Reliever Extra Strength by L.N.K. International, Inc.

Medically reviewed on March 6, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-519

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.

Quality Plus 44-519

Active ingredient
(in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever / fever reducer

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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

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.

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.

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 (1-800-222-1222) 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 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps 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 : do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

QUALITY PLUS                                                                                       NDC 50844-519-02

                                    *Compare to the active ingredient in Extra Strength TYLENOL® Rapid Release Gels

EXTRA STRENGTH
Pain Reliever
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER
NON-ASPIRIN

12 Rapid Release Gelcaps                                    Actual Size

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® Rapid Release Gels.

Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA                  50844    REV0513C51902

Quality Plus 44-519

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-519
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED, BLUEScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;5
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-519-151 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
2NDC:50844-519-021 BOTTLE, PLASTIC in 1 CARTON
212 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(50844-519), PACK(50844-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-519)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(50844-519)

 
L.N.K. International, Inc.

← See all Pain Reliever Extra Strength brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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