Wal-Sleep Z Pain Relief: Package Insert and Label Information

WAL-SLEEP Z PAIN RELIEF- acetaminophen and diphenhydramine hydrochloride solution
Walgreen Company

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 30 mL)

Acetaminophen 1,000 mg
Diphenhydramine HCl 50 mg

Purpose

Pain reliever
Nighttime sleep-aid

Use

for the temporary relief of occasional 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
• glaucoma

• a breathing problem such as emphysema or chronic bronchitis

• 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

• drowsiness will occur
• avoid alcoholic beverages
• 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.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

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

• mL = milliliter; FL OZ = fluid ounce

• only use the dose cup provided

• adults and children 12 years and over: take 30 mL in the dosing cup provided at bedtime. Do not take more than 30 mL of this product in 24 hours.

• children under 12 years: do not use

Other information

• each 30 mL contains: sodium 12 mg

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

• use by expiration date o package

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Principal display panel

Walgreens

Compare to ZzzQuil® NIGHT PAIN active ingredients††

NDC 0363-7400-02

NEW

Wal-Sleep Z +
Pain Relief
ACETAMINOPHEN 1,000 / DIPHENHYDRAMINE
HCl 50 mg/ PAIN RELIEVER / NIGHTTIME SLEEP-AID

NIGHTTIME
ALCOHOL FREE

•Non-habit forming
•Maximum strength pain reliever

12 FL OZ (355 mL)

MIDNIGHT BERRY FLAVOR

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey

††This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark ZzzQuil® NIGHT PAIN.
50844 ORG032107402

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD,. DEERFIELD, IL 60015100% SATISFACTION GUARANTEED walgreens.com ©2021 Walgreen Co.

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

Walgreens 44-074

WAL-SLEEP Z PAIN RELIEF acetaminphen, diphenhydramine hcl solution

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7400 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 1000 mg in 30 mL DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CHLORIDE TRISODIUM CITRATE DIHYDRATE SORBITOL SUCRALOSE XANTHAN GUM

Product Characteristics Color purple (dark) Score Shape Size Flavor BERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0363-7400-02 355 mL 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 06/02/2021

Labeler — Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		967626305	manufacture (0363-7400), pack (0363-7400)

Revised: 09/2021 Walgreen Company