FDA.reportPublic FDA data

SLEEP-AID

Manufacturer
Shield Pharmaceuticals Corp
Effective date
2026-08-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-20 01:01:13

Label at a glance#

ProductSLEEP AID
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

do not take more than directed take only one dose per day (24 hours) adults & children 12 yrs & over take 2 softgels at bedtime if needed or as directed by a doctor children under 12 years Do not use

Storage and handling

store at 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (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 SECTION

Warnings

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 asthma, 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

When using this product

OTC - WHEN USING SECTION

  • 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 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 1(800)222-1222 right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • take only one dose per day (24 hours)
adults & children 12 yrs & overtake 2 softgels at bedtime if needed or as directed by a doctor
children under 12 yearsDo not use

Other information

STORAGE AND HANDLING SECTION

  • store at 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

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, propylene glycol, polyethylene glycol-400, purified water, shellac, sorbitol solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981

OTC - QUESTIONS SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleep Aid

Diphenhydramine HCl 25 mg

Fall Asleep Fast

  • Non-Habit Forming
  • Not for treating Pain, Cold or Flu
  • Just for Sleep

Carton

Sleep Aid 8 ctSleep Aid 8 ct

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130611419406576GTIN-13: 0611419406576
EAN-13: 0611419406576
GTIN-12: 611419406576
UPC-A: 611419406576
GTIN storage (14 digits): 00611419406576		Sleep Aid 8 ct.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83059-007583059-0075-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
N-BUTYL ALCOHOL8PJ61P6TS3IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SORBITOL SOLUTION8KW3E207O2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsExact identifier
ndc (package): 83059-0075-8
ndc (product): 83059-0075
ndc11 (package): 83059007508
spl id: 5940c4e9-72d0-fafa-e063-6294a90aaf7a
spl set id: 4b6fc81e-e3ba-4a36-834c-82766311aa73

Reported adverse events (FAERS/openFDA)#

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