Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 2eb8da09-e6d6-467a-8fb8-fdf8a6738dad

Route

ORAL

Published

Effective Date 2024-05-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Anhydrous Citric Acid Propylene Glycol Polyoxyl 40 Stearate Water Sodium Benzoate Saccharin Sodium Anhydrous Trisodium Citrate Dihydrate High Fructose Corn Syrup Fd&c Blue No. 1 Alcohol Fd&c Red No. 40

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-06-30

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Uses

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

Directions

take only one dose per day (24 hours) - (see overdose warning)
mL= milliliter
keep dosing cup with product
measure only with dosing cup provided do not use any other dosing device
adults and children 12 years and over
- one dose=30 mL at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Do Not Use

with any other product containing diphenhydramine, even one used on the skin
for children under 12 years of age
with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Questions?

Or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4PM MST

Package Label

Winco Foods NightTime Sleep-Aid Berry Flavor

Other Information

each 30 mL contains: sodium 23 mg
store at 20-25ºC (68-77ºF)
do not refrigerate
protect from light

Inactive Ingredients

citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate

Principal Display Panel

*Compare to the active igredient in ZZZQUIL®

NIGHTTIME

Sleep Aid

DIPHENHYDRAMINE HCI 50 mg / NIGHTTIME SLEEP-AID

Not For Treating Cold or Flu

Safe, Non-Habit Forming

Alcohol 10%

Berry Flavor

FL OZ (mL)

FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES

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

*This product is not manufactured or distributed byThe Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

www.wincofoods.com

When Using This Product

drowsiness will occur
avoid alcoholic beverages and other drugs that cause drowsiness
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 30 Ml)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

a breathing problem such as asthma, emphysema, or chronic bronchitis
glaucoma
heart disease
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers or any other sleep-aid.

Structured Label Content

Uses

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

Purpose

Nighttime sleep-aid

Directions

take only one dose per day (24 hours) - (see overdose warning)
mL= milliliter
keep dosing cup with product
measure only with dosing cup provided do not use any other dosing device
adults and children 12 years and over
- one dose=30 mL at bedtime if needed, or as directed by a doctor
children under 12 years do not use

Do Not Use (Do not use)

with any other product containing diphenhydramine, even one used on the skin
for children under 12 years of age
with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Questions?

Or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4PM MST

Package Label

Winco Foods NightTime Sleep-Aid Berry Flavor

Other Information (Other information)

each 30 mL contains: sodium 23 mg
store at 20-25ºC (68-77ºF)
do not refrigerate
protect from light

Inactive Ingredients (Inactive ingredients)

Principal Display Panel

*Compare to the active igredient in ZZZQUIL®

NIGHTTIME

Sleep Aid

DIPHENHYDRAMINE HCI 50 mg / NIGHTTIME SLEEP-AID

Not For Treating Cold or Flu

Safe, Non-Habit Forming

Alcohol 10%

Berry Flavor

FL OZ (mL)

FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES

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

*This product is not manufactured or distributed byThe Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

www.wincofoods.com

When Using This Product (When using this product)

drowsiness will occur
avoid alcoholic beverages and other drugs that cause drowsiness
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 30 Ml) (Active ingredient (in each 30 mL))

Diphenhydramine HCl 50 mg

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

a breathing problem such as asthma, emphysema, or chronic bronchitis
glaucoma
heart disease
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers or any other sleep-aid.

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 STEARATE", "unii": "13A4J4NH9I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM ANHYDROUS", "unii": "I4807BK602", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH FRUCTOSE CORN SYRUP", "unii": "XY6UN3QB6S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "Purpose": "Nighttime sleep-aid", "Directions": "take only one dose per day (24 hours) - (see overdose warning) mL= milliliter keep dosing cup with product measure only with dosing cup provided do not use any other dosing device adults and children 12 years and over one dose=30 mL at bedtime if needed, or as directed by a doctor children under 12 years do not use ", "Do not use": "with any other product containing diphenhydramine, even one used on the skin for children under 12 years of age with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids", "Questions?": "Or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4PM MST", "Package Label": "Winco Foods NightTime Sleep-Aid Berry Flavor", "Other information": "each 30 mL contains : sodium 23 mg store at 20-25ºC (68-77ºF) do not refrigerate protect from light", "Inactive ingredients": "citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate", "Principal Display Panel": "*Compare to the active igredient in ZZZQUIL® NIGHTTIME Sleep Aid DIPHENHYDRAMINE HCI 50 mg / NIGHTTIME SLEEP-AID Not For Treating Cold or Flu Safe, Non-Habit Forming Alcohol 10% Berry Flavor FL OZ (mL) FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING . *This product is not manufactured or distributed byThe Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company. DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704 www.wincofoods.com", "When using this product": "drowsiness will occur avoid alcoholic beverages and other drugs that cause drowsiness be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each 30 mL)": "Diphenhydramine HCl 50 mg", "Ask a doctor before use if you have": "a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma heart disease trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers or any other sleep-aid."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:02.619593 · Updated: 2026-03-14T23:02:54.359020