Pain Relief PM Extra Strength: Package Insert and Label Information

PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet, coated
Family Dollar (FAMILY WELLNESS)

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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• with any other products containing diphenhydramine, even one used on skin
• in children under 12 years of age
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• liver disease
• a breathing problems such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• drowsiness will occur
• avoid alcoholic drinks
• 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.
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for 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.

Overdose warning: 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 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 between 20-25°C (68-77°F)
• avoid high humidity and excessive heat

Inactive ingredients

croscarmellose sodium*, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol* povidone K30, pregelatanized starch, purified water, silicon dioxide, sodium starch glycolate, talc, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO EXTRA STRENGTH TYLENOL® PM ACTIVE INGREDIENTS*

Extra Strength Pain Relief PM

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Pain Reliever, Nighttime Sleep Aid

Caplets

*This product is not manufactured or distributed by McNeil Consumer Healthcare distributor of Extra Strength Tylenol® PM.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY CHESAPEAKE, VA 23320

Package Label

FAMILY WELLNESS Extra Strength Pain Relief PM

PAIN RELIEF PM EXTRA STRENGTH acetaminophen, diphenhydramine hcl tablet, coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-863 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 CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 STARCH, CORN WATER SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A CORN TALC TITANIUM DIOXIDE ALUMINUM OXIDE

Product Characteristics Color blue Score no score Shape CAPSULE Size 18mm Flavor Imprint Code P525 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55319-863-10 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC 1 100 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the BOX (55319-863-10) 2 NDC:55319-863-50 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC 2 50 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the BOX (55319-863-50) 3 NDC:55319-863-24 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC 3 24 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the BOX (55319-863-24)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/28/2020 02/28/2025

Labeler — Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 01/2023 Family Dollar (FAMILY WELLNESS)