FDA.reportPublic FDA data

ZzzQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-07-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:27:53

Label at a glance#

ProductZzzQuil FREE OF
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure19 sections

Indications and uses

for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

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

Storage and handling

each 30 mL dose cup contains: sodium 88 mg store at no greater than 25°C

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL dose cup)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages

Stop use and ask a doctor

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose (30 mL) per day (24 hours)
  • only use dose cup provided
adults & children 12 yrs & over30 mL at bedtime if needed
or as directed by a doctor
children under 12 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL dose cup contains: sodium 88 mg
  • store at no greater than 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin, natural flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, water

Questions or comments?

OTC - QUESTIONS SECTION

1-877-881-5813

SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if printed shrinkband seal around the neck is broken or missing.

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vicks®

ZzzQuil™

Nighttime Sleep-Aid

Diphenhydramine HCl

Free Of

High Fructose Corn Syrup

Alcohol

Artificial Dyes & Flavors

Fall Asleep Fast

Non-habit Forming

12 FL OZ (354 mL)

965965

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-96569423-965-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE1Q73Q2JULRIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0321c480-e152-421d-e063-6294a90ad687d2a50e5a-170f-5530-e053-2a95a90a2f162023-08-17WarningsExact identifier
spl set id: d2a50e5a-170f-5530-e053-2a95a90a2f16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.