FDA.reportPublic FDA data

Sleep-Aid

Manufacturer
CVS PHARMACY | LNK International, Inc.
Effective date
2022-11-19
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:43:00

Label at a glance#

ProductSleep-Aid Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Storage and handling

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number protect from moisture

Label contents#

Full prescribing information#

Active ingredient (in each mini-capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness 

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
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
  • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium hydroxide, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health™

Compare to the active ingredient in Unisom® SleepMinis™*

Mini-Capsules

NDC 69842-682-11

Nighttime
Sleep-Aid
DIPHENHYDRAMINE HCl, 25 mg
Nighttime sleep-aid

Non-habit forming

60 MINI-CAPSULES

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR
MISSING OR IF BLUE BAND AROUND CAPSULE
IS BROKEN OR MISSING 

*This product is not manufactured or distributed by
Chattem, Inc., owner of the registered trademark
Unisom® SleepMinis™.
50844          ORG021668211


Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2017 CVS/Pharmacy
CVS.com® 1-800-SHOP CVS  V-11112

CVS®Quality
Money Back Guarantee

CVS Health 44-682
CVS Health 44-682

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-682-51EA - Each69842-68262a29b90-97d3-4d97-9da6-19bb4bf7642b12020-06-05

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-68269842-682-11, 69842-682-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
BUTYLPARABEN3QPI1U3FV8IACT
STARCH, CORNO8232NY3SJIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 3PN2ZH5LOQYIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SHELLAC46N107B71OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM HYDROXIDE55X04QC32IIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

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
2e3f55ac-c08e-4e2d-ad14-da3f0fb406db25fc32e2-8318-4601-bb34-ac25ff2f4ba42023-04-20WarningsExact identifier
spl set id: 25fc32e2-8318-4601-bb34-ac25ff2f4ba4

Reported adverse events (FAERS/openFDA)#

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