Vicks ZzzQuil

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-08-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:26:40

Label at a glance#

ProductVicks ZzzQuil Night Pain
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure19 sections

Dosage and administration

• take only one dose (30 mL) per day (24 hours) • only use the dose cup provided adults & children 12 yrs & over 30 mL at bedtime children under 12 yrs do not use

Storage and handling

each 30 mL contains:  sodium 151 mg store at no greater than 25°C and do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product

• taken with other drugs containing acetaminophen

• 3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause severe skin reactions.

Symptoms may include: • skin reddening • blisters • rash

If a skin reaction occurs, stop use and seek medical help right away

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a sodium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

These could be signs of a serious condition.

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.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

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

adults & children 12 yrs & over30 mL at bedtime
children under 12 yrsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 151 mg
  • store at no greater than 25°C and do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

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 - 354 ml bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

ZzzQuil™
NIGHT PAIN
NIGHTTIME SLEEP-AID

PAIN RELIEVER

Diphenhydramine HCl

Acetaminophen

Fall Asleep Fast

Max Strength Pain Reliever

Non-Habit Forming

Midnight Berry

Not for colds

Alcohol 10%

12 FL OZ (354 ml)

975975

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-97537000-975-12, 37000-975-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
065d78e6-3d65-4047-e063-6294a90aa87fa7d100bf-46ad-4279-e053-2a95a90a35062023-09-27WarningsExact identifier
spl set id: a7d100bf-46ad-4279-e053-2a95a90a3506

Reported adverse events (FAERS/openFDA)#

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