Pain Reliever

Manufacturer
L.N.K. International, Inc. | LNK International, Inc.
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:17:35

Label at a glance#

ProductPain Reliever
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains associated with headache toothache minor arthritis pain muscular aches the common cold menstrual cramps For the reduction of fever.

Dosage and administration

do not use more than directed Adults and children 12 years and over:   Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Storage and handling

store at room temperature 59 ̊-86 ̊F (15 ̊-30 ̊C) tamper-evident sealed packets do not use any opened or torn packets

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg


Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer


Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with

  • headache
  • toothache
  • minor arthritis pain
  • muscular aches
  • the common cold
  • menstrual cramps

For the reduction of fever.


Warnings

WARNINGS SECTION

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

  • more than 8 tablets 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:

  • 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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

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 accidental 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 use more than directed

Adults and children 12 years and over:

 

Take 2 tablets every 4 to 6
hours as needed. Do not take
more than 8 tablets in 24 hours.

Children under 12 years:

Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.





Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 59 ̊-86 ̊F (15 ̊-30 ̊C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

*may contain


Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391


Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
PLUS

NDC 50844-270-24

†Compare to active ingredient in Extra Strength Tylenol®

EXTRA STRENGTH
PAIN RELIEVER
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER

CONTAINS NO ASPIRIN

60 Packets
of 2 Tablets each
500 mg each

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
OR IF PACKET IS TORN, BROKEN OR SHOWS ANY SIGNS
OF TAMPERING

†This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol®.

50844 ORG

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

44-745
44-745

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50844-27050844-270-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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
0dcdc9ff-4f19-4162-b6ac-528c815011575aa8d99b-7a38-4f01-a95f-baf0f57296ed2024-06-17WarningsExact identifier
spl set id: 5aa8d99b-7a38-4f01-a95f-baf0f57296ed

Reported adverse events (FAERS/openFDA)#

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