Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9
Route
ORAL
Published
Effective Date 2024-07-22
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 Alcohol Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-03-31
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=30 mL at bedtime if needed, or as directed by a doctor
  • children under 12 years do not use 


Do Not Use
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Package Label
DOLLAR GENERAL Night Time Sleep Aid
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

Questions Or Comments?

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredient of ZzzQUIL®*

Night Time

Sleep Aid

Diphenhydramine HCI 50 mg

Non-habit forming

Not for treating cold or flu

ALCOHOL 10%

Mixed 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 by Procter & Gamble Company. ZzzQUIL® is a registered trademark of the Procter & Gamble Company.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

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 a serous underling medical illness

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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=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)
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Package Label
DOLLAR GENERAL Night Time Sleep Aid
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

Questions Or Comments? (Questions or comments?)

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredient of ZzzQUIL®*

Night Time

Sleep Aid

Diphenhydramine HCI 50 mg

Non-habit forming

Not for treating cold or flu

ALCOHOL 10%

Mixed 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 by Procter & Gamble Company. ZzzQUIL® is a registered trademark of the Procter & Gamble Company.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

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 a serous underling 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.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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)
  • a breathing problem such as 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:19.654981 · Updated: 2026-03-14T23:03:20.235753