MedPath

ZzzQuil

ZzzQuil™NIGHTTIME SLEEP-AID LIQUICAPS

Approved
Approval ID

ad4babdb-d98d-420e-b8b0-9a5368c89a44

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

The Procter & Gamble Manufacturing Company

DUNS: 004238200

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diphenhydramine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37000-501
Application NumberM010
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (13)

DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/11/2025

PRINCIPAL DISPLAY PANEL - 12 LiquiCap Carton

VICKS ®

ZzzQuil™

NIGHTTIME SLEEP-AID
Diphenhydramine HCl

Not for colds or for pain

Fall Asleep Fast

Non-Habit Forming

12 LIQUICAPS™

501

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/31/2023

Uses

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/31/2023

Keep out of reach of children.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 8/31/2023

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/11/2025

Inactive ingredients

asorbic acid, FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, mannitol, polyethylene glycol, shellac, simethicone, sorbitan, sorbitol, titanium dioxide, water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/31/2023

Questions?

1-877-881-5813

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/31/2023

Directions

• take only one dose (2 LiquiCaps) per day (24 hours)

adults & children 12 yrs & over

2 LiquiCaps at bedtime if needed or as directed by a doctor

children under 12 yrs

do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/25/2023

Other information

  • store at no greater than 25°C (77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/31/2023

MADE IN CANADA.

DIST. BY: PROCTER & GAMBLE,

CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/31/2023

Active ingredients (in each liquicap)

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/31/2023

Purpose

Nighttime sleep-aid

WARNINGS SECTION

LOINC: 34071-1Updated: 8/31/2023

Warnings

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

LOINC: 50569-3Updated: 8/31/2023

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

LOINC: 50568-5Updated: 8/31/2023

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/31/2023

When using this product

  • avoid alcoholic beverages

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/31/2023

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 8/31/2023

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

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