Zzzquil™

Zzzquil™
SPL v3
SPL
SPL Set ID 1d608c94-1651-f318-e063-6294a90aa11e
Route
ORAL
Published
Effective Date 2026-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Alcohol Fd&c Blue No. 1 Sorbitol Fd&c Red No. 40 Water Saccharin Sodium Sodium Benzoate Sucralose Sodium Citrate Xanthan Gum Polysorbate 20 Glycerin Citric Acid Monohydrate

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-15

Description

Drug Facts

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take only one dose (30 mL) per day (24 hours)
  • only use dose cup provided
adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor
children under 12 yrs do not use



Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions?

1-877-881-5813

Other Information
  • each 30 mL dose contains: sodium 23 mg
  • store at no greater than 25ºC
Inactive Ingredients

alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polysorbate 20, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

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.

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
Active Ingredient (in Each 30 Ml Dose Cup)

Diphenhydramine HCl 50 mg

Principal Display Panel 118 Ml Bottle Label

VICKS ®

ZzzQuil

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Fall Asleep Fast

Non-Habit Forming



Alcohol 10%

4 FL OZ (118 mL)


Structured Label Content

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nighttime sleep-aid

Directions
  • take only one dose (30 mL) per day (24 hours)
  • only use dose cup provided
adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor
children under 12 yrs 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
Questions?

1-877-881-5813

Other Information (Other information)
  • each 30 mL dose contains: sodium 23 mg
  • store at no greater than 25ºC
Inactive Ingredients (Inactive ingredients)

alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, polysorbate 20, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

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.

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
  • difficulty in urination due to enlargement of the prostate gland
Active Ingredient (in Each 30 Ml Dose Cup) (Active ingredient (in each 30 mL dose cup))

Diphenhydramine HCl 50 mg

Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label)

VICKS ®

ZzzQuil

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Fall Asleep Fast

Non-Habit Forming



Alcohol 10%

4 FL OZ (118 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)