FDA.reportPublic FDA data

Sleep-Aid

Manufacturer
P & L Development, LLC
Effective date
2021-10-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:30:39

Label at a glance#

ProductSleep-Aid Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 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 (2 softgels) per day (24 hours)  swallow whole; do not crush, chew, or dissolve adults & children 12 years and over: take 2 softgels at bedtime, if needed, or as directed by a doctor children under 12 years of age: do not use

Storage and handling

store between 20-25° C (68-77° F) avoid excessive heat above 40° C (104° F) and high humidity protect from light

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema, or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers or any other sleep-aid.

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose (2 softgels) per day (24 hours) 
  • swallow whole; do not crush, chew, or dissolve
  • adults & children 12 years and over: take 2 softgels at bedtime, if needed, or as directed by a doctor
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol*, purified water, sorbitol, sorbitan

*may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

nighttime sleep-aid

Diphenhydramine HCl 25 mg

nighttime sleep-aid

  • non habit-forming
  • not for treating cold or flu

See Warnings

softgels**

(**liquid-filled capsules)

†Compare to the active ingredient in ZZZQUIL®

This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: PL Developments,

200 Hicks Street,

Westbury, NY 11590

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WELLNESS BASICS Nighttime Sleep-Aid
WELLNESS BASICS Nighttime Sleep-Aid

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-40559726-405-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
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
8acb0ca2-7583-4cb8-a159-869eb205b138dae2ab2e-97c6-4407-bbf3-091f2960ad782021-10-26WarningsExact identifier
spl id: 8acb0ca2-7583-4cb8-a159-869eb205b138
spl set id: dae2ab2e-97c6-4407-bbf3-091f2960ad78

Reported adverse events (FAERS/openFDA)#

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