Pain Relief PM Extra Strength: Package Insert and Label Information

PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet, coated
QUALITY CHOICE (Chain Drug Marketing Association)

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 geltab)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep-aid

Purposes

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 product 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 problem 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 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.

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 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours.
• children under 12 years: do not use

Other information

• store between 20-25ºC (68-77ºF)
• avoid high humidity and excessive heat

Inactive ingredients

corn starch, croscarmellose sodium, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal display panel

*Compare to the active ingredients in Extra Strength TYLENOL® PM

Extra Strength

PAIN RELIEF PM

Pain Reliever | Nighttime Sleep-Aid

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Non-habit forming

GELTABS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tyleno® 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: C.D.M.A., Inc.©

43157 W. 9 Mile Rd

Novi, MI 48376-0995

www.qualitychoice.com

Product Label

QUALITY CHOICE Pain Relief PM

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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-119 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 STARCH, CORN D&C RED NO. 27 FD&C BLUE NO. 1 GELATIN GLYCERIN HYPROMELLOSES MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE WATER SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE CROSCARMELLOSE SODIUM ALUMINUM OXIDE SODIUM STARCH GLYCOLATE TYPE A CORN

Product Characteristics Color white, blue Score no score Shape OVAL Size 13mm Flavor Imprint Code BP50 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63868-119-50 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC 1 50 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the BOX (63868-119-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/31/2015 05/30/2025

Labeler — QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 11/2022 QUALITY CHOICE (Chain Drug Marketing Association)