Nighttime Sleep-aid

SPL v8

SPL

SPL Set ID 048cfa3a-4519-400d-a5ab-ce05c9cc4ec8

Route

ORAL

Published

Effective Date 2025-11-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Potassium Citrate Water Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-01-25

Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Uses

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Section 50566-9

Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

take only one dose per day (24 hours)
only use the dose cup provided

adults & children 12 yrs & over	30 mL at bed time if needed or as directed by a doctor
children under 12 yrs	do not use

Do Not Use

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

Other Information

each 30 mL dose cup contains:potassium 5 mg; sodium 10 mg
store at room temperature

Inactive Ingredients

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Questions Or Comments?

1-866-467-2748

When Using This Product

avoid alcoholic beverages

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Principal Display Panel 354 Ml Label

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

Nighttime Sleep-aid

Diphenhydramine HCl

Non-Habit Forming

Makes you fall asleep fast

Alcohol-Free

Cherry Vanilla Flavor

Naturally and Artificially Flavor

Not for Pain, Not for Colds, Just for Sleep

12 FL. OZ. (354 ml)

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Package Label for Nighttime Sleep-Aid

Active Ingredient (in Each 30 Ml Dose Cup)

Diphenhydramine HCl 50 mg

Package Label for Nighttime Sleep Aid Twin Pack

Structured Label Content

Uses

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nighttime sleep-aid

Directions

take only one dose per day (24 hours)
only use the dose cup provided

adults & children 12 yrs & over	30 mL at bed time if needed or as directed by a doctor
children under 12 yrs	do not use

Do Not Use (Do not use)

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

Other Information (Other information)

each 30 mL dose cup contains:potassium 5 mg; sodium 10 mg
store at room temperature

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)

avoid alcoholic beverages

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Principal Display Panel 354 Ml Label (Principal Display Panel - 354 mL Label)

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

Nighttime Sleep-aid

Diphenhydramine HCl

Non-Habit Forming

Makes you fall asleep fast

Alcohol-Free

Cherry Vanilla Flavor

Naturally and Artificially Flavor

Not for Pain, Not for Colds, Just for Sleep

12 FL. OZ. (354 ml)

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Package Label for Nighttime Sleep-Aid

Active Ingredient (in Each 30 Ml Dose Cup) (Active ingredient (in each 30 mL dose cup))

Diphenhydramine HCl 50 mg

Package Label for Nighttime Sleep Aid Twin Pack (Package Label for Nighttime Sleep Aid Twin-Pack)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222", "50566-9": "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "Purpose": "Nighttime sleep-aid", "Directions": "take only one dose per day (24 hours) only use the dose cup provided adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor children under 12 yrs do not use", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "Other information": "each 30 mL dose cup contains: potassium 5 mg; sodium 10 mg store at room temperature", "Inactive ingredients": "anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.", "Questions or comments?": "1-866-467-2748", "When using this product": "avoid alcoholic beverages", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland", "Principal Display Panel - 354 mL Label": "Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid* Nighttime Sleep-aid Diphenhydramine HCl Non-Habit Forming Makes you fall asleep fast Alcohol-Free Cherry Vanilla Flavor Naturally and Artificially Flavor Not for Pain, Not for Colds, Just for Sleep 12 FL. OZ. (354 ml) *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 Walgreens.com ©2017 Walgreen Co. Package Label for Nighttime Sleep-Aid", "Active ingredient (in each 30 mL dose cup)": "Diphenhydramine HCl 50 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:21.405649 · Updated: 2026-03-14T23:10:42.831626