Sleep-Aid

Manufacturer
CVS Pharmacy | LNK International, Inc.
Effective date
2020-03-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:39:32

Label at a glance#

ProductSleep-Aid Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

for 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 and children 12 years and over: take 2 capsules at bedtime if needed or as directed by a doctor children under 12 years: do not use

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN  see end flap for expiration date and lot number store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from heat, humidity and light

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • for 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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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

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

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
  • see end flap for expiration date and lot number
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from heat, humidity and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSHealth™

Compare to the active ingredient
in ZzzQuil® LiquiCaps®*

NDC 69842-658-08

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCl, 25 mg - Nighttime sleep-aid

Free of artificial dyes & preservatives

Non-habit forming capsules
Relieves occasional sleeplessness

24 LIQUID-FILLED CAPSULES

Actual Size

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark ZzzQuil® LiquiCaps®.

50844  ORG081765808

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com 1-800-SHOP CVS

Product of China
Packaged and Quality Assured in the U.S.A.
V-11112

CVS Quality
Money Back Guarantee

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

CVS 44-658CVS 44-658

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-65869842-658-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
b1126b89-a7fa-41f1-93dd-7c7963663bed88e97f73-0f2d-49aa-b56a-54e7a07d9f462020-03-10WarningsExact identifier
spl id: b1126b89-a7fa-41f1-93dd-7c7963663bed
spl set id: 88e97f73-0f2d-49aa-b56a-54e7a07d9f46

Reported adverse events (FAERS/openFDA)#

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