FDA.reportPublic FDA data

ZzzQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2022-07-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:56:06

Label at a glance#

ProductZzzQuil Soothing Berry
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 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 (30mL) per day (24 hours) only use the 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

Storage and handling

each 30 mL contains: sodium 88 mg store at no greater than 25ºC

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

OTC - DO NOT USE SECTION

Do not use

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • avoid alcoholic beverages

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose (30mL) per day (24 hours)
  • only use the 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

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 88 mg
  • store at no greater than 25ºC

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

DIST. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

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

Soothing Berry

Not for colds or for pain

12 FL OZ (354 ml)

930930

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37000-930-062021-02-12C16284748780-1ba0f9c33-31bf-a910-e053-dadaa90a0b85ZzzQuil™ Soothing Berry Flavor
37000-930-122021-02-12C16284748780-1ba0f9c33-31bf-a910-e053-dadaa90a0b85ZzzQuil™ Soothing Berry Flavor
37000-930-242021-02-12C16284748780-1ba0f9c33-31bf-a910-e053-dadaa90a0b85ZzzQuil™ Soothing Berry Flavor
37000-930-062021-01-29C16284748780-1ba0f9c33-31bf-a910-e053-dadaa90a0b85ZzzQuil™ Soothing Berry Flavor
37000-930-122021-01-29C16284748780-1ba0f9c33-31bf-a910-e053-dadaa90a0b85ZzzQuil™ Soothing Berry Flavor
37000-930-242021-01-29C16284748780-1ba0f9c33-31bf-a910-e053-dadaa90a0b85ZzzQuil™ Soothing Berry Flavor

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
37000-93037000-930-06, 37000-930-12, 37000-930-24

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CHLORIDE451W47IQ8XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
POLYSORBATE 207T1F30V5YHIACT
SUCRALOSE96K6UQ3ZD4IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT

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
ef53cbad-bbd6-a06a-e053-2995a90a500b8dbbef23-8746-935e-e053-2a95a90af25c2022-12-08WarningsExact identifier
spl set id: 8dbbef23-8746-935e-e053-2a95a90af25c

Reported adverse events (FAERS/openFDA)#

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