Pain Reliever: Package Insert and Label Information

PAIN RELIEVER- acetaminophen tablet
L.N.K. International, Inc.

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.

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 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

• 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 the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days in adults
• new symptoms occur
• pain gets worse or lasts more than 5 days in children under 12 years
• fever gets worse or lasts more than 3 days
• 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 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 4 to 6 hours while symptoms last ■ do not take more than 10 tablets in 24 hours ■ do not take for more than 10 days unless directed by a doctor
children 6-11 years	■ take 1 tablet every 4 to 6 hours while symptoms last ■ do not take more than 5 tablets in 24 hours ■ do not take for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

Inactive ingredients

corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal display panel

QUALITY +PLUS

NDC 50844-104-16

*Compare to
active ingredient in
Tylenol® Regular Strength

REGULAR STRENGTH
PAIN RELIEVER
Acetaminophen 325 mg
PAIN RELIEVER/FEVER REDUCER

ACTUAL SIZE

1000 Tablets

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 Tylenol® Regular Strength. 50844 ORG042110416

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

Quality Plus 44-104

PAIN RELIEVER acetaminophen tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-104 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID

Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 44;104 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50844-104-16 1000 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/25/2023

Labeler — L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	pack (50844-104)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	manufacture (50844-104)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	pack (50844-104)

Revised: 05/2023 L.N.K. International, Inc.