Pain Reliever

Manufacturer
L.N.K. International, Inc. | LNK International, Inc.
Effective date
2025-11-15
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:19:24

Label at a glance#

ProductPain Reliever Extra Strength
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed 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: ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each gelcap)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center 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

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • 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: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
+PLUS

NDC 50844-519-21

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

EXTRA STRENGTH
PAIN RELIEVER
Acetaminophen 500 mg

PAIN RELIEVER/FEVER REDUCER

16 Gelcaps

CONTAINS NO ASPIRIN

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 Johnson & Johnson Corporation, owner of the
registered trademark Extra Strength Tylenol®
Rapid Release Gels.    50844  ORG032251921

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

Quality Plus 44-519
Quality Plus 44-519

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN17
198440acetaminophen 500 MG Oral TabletSCD17
198440APAP 500 MG Oral TabletSY17

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050844519213GTIN-13: 0050844519213
EAN-13: 0050844519213
GTIN-12: 050844519213
UPC-A: 050844519213
GTIN storage (14 digits): 00050844519213
quality-plus-44-519-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50844-519-02Pain RelieverExtra Strength12 in 1 BOTTLE, PLASTICTABLET, COATED1217
50844-519-02Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED117
50844-519-12Pain RelieverExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10017
50844-519-15Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED117
50844-519-15Pain RelieverExtra Strength50 in 1 BOTTLETABLET, COATED5017
50844-519-20Pain RelieverExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED22517
50844-519-21Pain RelieverExtra Strength1 in 1 CARTONTABLET, COATED117
50844-519-21Pain RelieverExtra Strength16 in 1 BOTTLE, PLASTICTABLET, COATED1617

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH482
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3572
GELATININACTIVE INGREDIENT2G86QN327L2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671P2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
POVIDONESINACTIVE INGREDIENTFZ989GH94E2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50844-51950844-519-12, 50844-519-20, 50844-519-21, 50844-519-15, 50844-519-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 84 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, COATED / ORAL13.6 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, COATED / ORAL13.6 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET, COATED / ORALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET, COATED / ORALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, COATED / ORAL13.6 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, COATED / ORAL13.6 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, COATED / ORAL13.6 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET, COATED / ORALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE H)HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PTABLET, COATED / ORAL13.6 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.72babe91-2586-4f05-ae90-6debfd23aa5d2025-11-15WarningsExact identifier
ndc (package): 50844-519-02
ndc (package): 50844-519-20
ndc (package): 50844-519-15
ndc (package): 50844-519-12
ndc (package): 50844-519-21
ndc (product): 50844-519
ndc11 (package): 50844051920
ndc11 (package): 50844051915
ndc11 (package): 50844051912
ndc11 (package): 50844051921
ndc11 (package): 50844051902
spl id: 9f5e3344-4f7b-4096-a4f0-929e140c175c
spl set id: 72babe91-2586-4f05-ae90-6debfd23aa5d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.