Pain Relief PM: Package Insert and Label Information

PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet, film coated
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 ingredients (in each caplet)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

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

• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age

• 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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• liver disease
• glaucoma

• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers

When using this product

• avoid alcoholic beverages
• drowsiness will occur

• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

• redness or swelling is present
• new symptoms occur

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

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 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.

• children under 12 years: do not use

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

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

SOUNDBODY™

*Compare to the active ingredients in Extra Strength Tylenol^® PM

NDC 50844-539-12

EXTRA STRENGTH
Pain Relief PM

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever/Nighttime Sleep-Aid

100 CAPLETS

Non-habit forming

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^® PM.

50844 ORG041723512

Manufactured for Big Lots Stores, Inc.
by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge NY, 11788 USAV#733000 ITEM#022723512

Sound Body 44-235

PAIN RELIEF PM acetaminophen, diphenhydramine hcl tablet, film coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-539 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 ALUMINUM LAKE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED STEARIC ACID TALC TITANIUM DIOXIDE

Product Characteristics Color blue Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;235 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50844-539-12 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (50844-539-12)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/01/2019 07/27/2023

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

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	pack (50844-539)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867837	manufacture (50844-539), pack (50844-539)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		868734088	pack (50844-539)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	pack (50844-539)

Revised: 07/2022 L.N.K. International, Inc.