FDA.reportPublic FDA data

Sleep Aid

Manufacturer
PLD Acquisitions LLC DBA Avéma Pharma Solutions
Effective date
2023-02-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:37:02

Label at a glance#

ProductSleep Aid Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

For relief of occasional sleeplessness

Dosage and administration

take only one dose (2 caplets) per day (24 hours) adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

For relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in children under 12 years of age
  • with any other products 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 sedative or tranquilizers.

When using this product,

OTC - WHEN USING SECTION

avoid alcoholic drinks.

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

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 caplets) per day (24 hours)
  • adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
  • children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • each caplet contains: calcium 25 mg
  • store between 20-25°C (68-77°F); excursions permitted between 15-30ºC (59-86ºF) 

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Tylenol® Simply Sleep®†

Nighttime Sleep-Aid

Diphenhydramine HCl, 25 mg

Does NOT contain pain reliever

Fall asleep fast

Wake up rested

Non habit-forming

Caplets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor Tylenol® Simply Sleep®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nighttime Sleep-Aid
Nighttime Sleep-Aid

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63548-0400-12023-02-09C16284748780-1f386c649-dfcd-0266-e053-dadaa90a7c1aDrug Facts
63548-0400-12023-01-30C16284748780-1f386c649-dfcd-0266-e053-dadaa90a7c1aDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63548-040063548-0400-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TALC7SEV7J4R1UIACT
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
5463dfbf-3470-439a-96cb-d330893bb9c4b30a751b-95fe-4eac-8fe7-d7ef67165b152023-02-09WarningsExact identifier
spl id: 5463dfbf-3470-439a-96cb-d330893bb9c4
spl set id: b30a751b-95fe-4eac-8fe7-d7ef67165b15

Reported adverse events (FAERS/openFDA)#

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