Quality Choice Nighttime Sleep-aid

SPL v1

SPL

SPL Set ID 3ce00c99-1a9b-41f1-a99a-35e03730dff0

Route

ORAL

Published

Effective Date 2024-08-23

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 Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-04

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 two weeks. Insomnia may be a symptom of 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 dose cup provided.


adults & children 12 yrs & over	30 mL at bedtime 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 contains: potassium 5 mg; sodium 10 mg
store at room temperature

Inactive Ingredients

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

QUALITY CHOICE

NDC 83324-336-06

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

Nighttime Sleep-Aid

Fall Asleep Fast

Diphenhydramine HCl

No added alcohol

Not for Pain. Not for Colds.

Just for sleep.

Berry Flavor

Naturally & Artificially Flavored

6 FL OZ (177 mL)

TAMPER EVIDENT: Do not use if printed shrink band is missing or broken

DISTRIBUTED BY: CDMA, Inc,

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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

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

Active Ingredient (in Each 30 Ml Dose Cup)

Diphenhydramine HCl 50 mg

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 two weeks. Insomnia may be a symptom of 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 dose cup provided.


adults & children 12 yrs & over	30 mL at bedtime 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 contains: potassium 5 mg; sodium 10 mg
store at room temperature

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

QUALITY CHOICE

NDC 83324-336-06

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

Nighttime Sleep-Aid

Fall Asleep Fast

Diphenhydramine HCl

No added alcohol

Not for Pain. Not for Colds.

Just for sleep.

Berry Flavor

Naturally & Artificially Flavored

6 FL OZ (177 mL)

TAMPER EVIDENT: Do not use if printed shrink band is missing or broken

DISTRIBUTED BY: CDMA, Inc,

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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

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

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

Diphenhydramine HCl 50 mg

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 two weeks. Insomnia may be a symptom of 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 dose cup provided. adults & children 12 yrs & over 30 mL at bedtime 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 contains : potassium 5 mg; sodium 10 mg store at room temperature", "Inactive ingredients": "anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.", "Questions or comments?": "1-866-467-2748", "PRINCIPAL DISPLAY PANEL": "QUALITY CHOICE NDC 83324-336-06 *Compare to the active ingredient in ZzzQuil ™ Nighttime Sleep-Aid Nighttime Sleep-Aid Fall Asleep Fast Diphenhydramine HCl No added alcohol Not for Pain. Not for Colds. Just for sleep. Berry Flavor Naturally & Artificially Flavored 6 FL OZ (177 mL) TAMPER EVIDENT: Do not use if printed shrink band is missing or broken DISTRIBUTED BY: CDMA, Inc, Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.", "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", "Active ingredient (in each 30 mL dose cup)": "Diphenhydramine HCl 50 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:50.497089 · Updated: 2026-03-14T23:09:50.407692