FDA.reportPublic FDA data

MAXIMUM STRENGTH SLEEP AID

Manufacturer
SPIRIT PHARMACEUTICALS LLC
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:46:36

Label at a glance#

ProductMAXIMUM STRENGTH SLEEP AID
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime, if needed, or as directed by a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)                           

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

for the relief of occasional sleeplessness

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
  • trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

sleeplessness persist continuosly 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 right away. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime, if needed, or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 8 softgels Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED™

MAXIMUM STRENGTH

SLEEP AID

  • Diphenhydramine HCl 50 mg

     Nighttime Sleep-Aid

Helps reduce difficulty falling asleep

Fast acting, Non-habit forming

Actual Size

8 softgels

PRINCIPAL DISPLAY PANEL - 8 softgels Bottle CartonPRINCIPAL DISPLAY PANEL - 8 softgels Bottle Carton

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
68210-020268210-0202-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
29b8cc8c-4d51-6192-e063-6294a90ad60c14b6a495-4516-4ed6-90dc-d1009b7de3102024-12-20WarningsExact identifier
spl set id: 14b6a495-4516-4ed6-90dc-d1009b7de310

Reported adverse events (FAERS/openFDA)#

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