Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID f85f73a2-9300-4b9b-89ab-f0d389d79c3c

Route

ORAL

Published

Effective Date 2013-03-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycols Water Fd&c Red No. 40 Sorbitol Titanium Dioxide Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: A41 Shape: capsule Color: purple Size: 15 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-03-11

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 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
swallow whole; do not crush, chew, or dissolve
adults & children 12 yrs & over
- one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor

Do Not Use

with any other product containing diphenhydramine, even one used on 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

Product Label

Quality Choice EZ Sleep Softgel

Other Information

store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F) and high humidity
protect from light

Inactive Ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

Questions Or Comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in ZZZQUIL®

EZ Nite Sleep

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

Non Habit-Forming

Not for Treating Cold or Flu | See Warnings

Softgels**

(**Liquid-filled capsules)

*This product is not manufactured or distributed by The Procter & Gamble Company. VICKS®, LIQUICAPS®, and ZZZQUIL® are registered trademarks of The Procter & Gamble Company.

©Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product of Canada

Failure to follow these warnings could result in serious consequences.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

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 a 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 Softgel)

Diphenhydramine HCl 25 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
swallow whole; do not crush, chew, or dissolve
adults & children 12 yrs & over
- one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor

Do Not Use (Do not use)

with any other product containing diphenhydramine, even one used on 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

Product Label

Quality Choice EZ Sleep Softgel

Other Information (Other information)

store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F) and high humidity
protect from light

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in ZZZQUIL®

EZ Nite Sleep

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

Non Habit-Forming

Not for Treating Cold or Flu | See Warnings

Softgels**

(**Liquid-filled capsules)

*This product is not manufactured or distributed by The Procter & Gamble Company. VICKS®, LIQUICAPS®, and ZZZQUIL® are registered trademarks of The Procter & Gamble Company.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product of Canada

Failure to follow these warnings could result in serious consequences.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

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 a 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 Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 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": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOLS", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "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 swallow whole; do not crush, chew, or dissolve adults & children 12 yrs & over one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor", "Do not use": "with any other product containing diphenhydramine, even one used on 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", "Product Label": "Quality Choice EZ Sleep Softgel ", "Other information": "store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) and high humidity protect from light", "Inactive ingredients": "FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide", "Questions or comments?": "Call 1-248-449-9300 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "*Compare to the active ingredient in ZZZQUIL® EZ Nite Sleep Nighttime Sleep-Aid Diphenhydramine HCl 25 mg Non Habit-Forming Not for Treating Cold or Flu | See Warnings Softgels** (**Liquid-filled capsules) *This product is not manufactured or distributed by The Procter & Gamble Company. VICKS®, LIQUICAPS®, and ZZZQUIL® are registered trademarks of The Procter & Gamble Company. ©Distributed by C.D.M.A., Inc. 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Product of Canada Failure to follow these warnings could result in serious consequences. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.", "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 a 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 softgel)": "Diphenhydramine HCl 25 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

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Source: dailymed · Ingested: 2026-02-15T11:55:42.495013 · Updated: 2026-03-14T22:53:36.648209