Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 21a68c60-3005-43bb-8ec5-7982239c93f8
Route
ORAL
Published
Effective Date 2025-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Anhydrous Citric Acid Propylene Glycol Polyoxyl Stearate 40 Water Sodium Benzoate Saccharin Sodium Anhydrous Trisodium Citrate Dihydrate High Fructose Corn Syrup Fd&c Blue No. 1 Fd&c Red No. 40 Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-30
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)
  • 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=30mL 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 skin
  • for children under 12 years of age
Package Label
SIGNATURE SELECT Nighttime Sleep Aid Berry Flavor
Other Information
  • each 30 mL contains: sodium 23 mg
  • store between 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, sodium citrate dihydrate

Principal Display Panel

COMPARE TO ZZZQUIL™ active ingredient*

NIGHTTIME SLEEP AID

NIGHTTIME SLEEP-AID

DIPHENHYDRAMINE HCI 50 mg

  • Not for treating cold or flu
  • 10 % alcohol

BERRY FLAVOR

fl oz (mL)

Failure to follow these warnings could results 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 by The Procter & Gamble Company. ZZZQUI™ is a registered trademark of The Proctor & Gamble Company.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99,

PLEASANTON, CA 94566-0009

When Using This Product
  • avoid alcoholic beverages.
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: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Active Ingredient (in Each 30 Ml)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have
  • breathing problem such as asthma emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

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)
  • 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=30mL 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 skin
  • for children under 12 years of age
Package Label
SIGNATURE SELECT Nighttime Sleep Aid Berry Flavor
Other Information (Other information)
  • each 30 mL contains: sodium 23 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
  • protect from light
Inactive Ingredients (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, sodium citrate dihydrate

Principal Display Panel

COMPARE TO ZZZQUIL™ active ingredient*

NIGHTTIME SLEEP AID

NIGHTTIME SLEEP-AID

DIPHENHYDRAMINE HCI 50 mg

  • Not for treating cold or flu
  • 10 % alcohol

BERRY FLAVOR

fl oz (mL)

Failure to follow these warnings could results 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 by The Procter & Gamble Company. ZZZQUI™ is a registered trademark of The Proctor & Gamble Company.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99,

PLEASANTON, CA 94566-0009

When Using This Product (When using this product)
  • avoid alcoholic beverages.
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: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) 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)
  • breathing problem such as asthma emphysema or chronic bronchitis
  • glaucoma
  • 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:28.281122 · Updated: 2026-03-14T23:09:15.187219