Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 5b005bfc-f588-4abc-8bb1-4691b40448cd
Route
ORAL
Published
Effective Date 2024-10-07
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 40 Stearate Type I 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 2018-03-31

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
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Package Label
DOLLAR GENERAL HEALTH Nighttime Sleep Aid Vanilla Cherry Flavor
Other Information
  • each 30 mL contains: sodium 22 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
  • protect from light
Inactive Ingredients

citric acid, 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

Nighttime Sleep-Aid

Non-habit forming

Not For Treating Cold or Flu

ALCOHOL 10%

Vanilla Cherry 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 The 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 serious underlying 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 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)
  • 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)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Package Label
DOLLAR GENERAL HEALTH Nighttime Sleep Aid Vanilla Cherry Flavor
Other Information (Other information)
  • each 30 mL contains: sodium 22 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
  • protect from light
Inactive Ingredients (Inactive ingredients)

citric acid, 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

Nighttime Sleep-Aid

Non-habit forming

Not For Treating Cold or Flu

ALCOHOL 10%

Vanilla Cherry 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 The 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 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.)

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 or any other sleep-aid.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)