FDA.reportPublic FDA data

CVS Health Nighttime Sleep-Aid Value Twin Pack 2 Bottles 12 FL OZ Each

Manufacturer
CVS Pharmacy,Inc.
Effective date
2026-08-18
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-21 02:02:22

Label at a glance#

ProductCVS Health Nighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

▪ for the relief of occasional sleeplessness ▪ reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

▪ take only one dose per day (24 hours) – see Overdose warning ▪ Measure with dosing cup provided adults & children 12 yrs & over One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor Children under 12 yrs do not use

Storage and handling

▪ each 30 mL dose contains: potassium 5mg; sodium 10 mg ▪ store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 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

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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

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
  • heart disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep- aid.

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than two 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.

Overdose warning:

SPL UNCLASSIFIED SECTION

Taking more than directed can cause serious health problems. 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 per day (24 hours) – see Overdose warning
  • Measure with dosing cup provided

adults & children 12 yrs & over

One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

Children under 12 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL dose contains: potassium 5mg; sodium 10 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE TWIN PACK

CVS Health™

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

NDC 59779-893-24

SEE NEW WARNINGS

Alcohol Free

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCL

  • Non-habit forming
  • Not for treating cold or flu

Berry Flavor

Naturally & artificially flavored

2 BOTTLES

12 FL OZ (354 mL) EACH;

24 FL OZ (708 mL) TOTAL

Failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Proctor & Gamble, the distributor of ZzzQuil™ Nighttime Sleep- Aid.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2019 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-30486

CVS ®Quality

Money Back Guarantee

CVS Health Nighttime Sleep -Aid Value Twin pack 2 Bottles
CVS Health Nighttime Sleep -Aid Value Twin pack 2 Bottles

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-89359779-893-24

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CITRATEEE90ONI6FFIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-09full-release2026-06-01 01:21:30

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsExact identifier
ndc (product): 59779-893
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsExact identifier
ndc (package): 59779-893-24
ndc (product): 59779-893
ndc11 (package): 59779089324
spl id: 0d0290a4-671f-43f0-acb8-eec3b084a99c
spl set id: e8785ba8-e53e-491e-bbfe-04e860f36131
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsExact identifier
ndc (product): 59779-893

Reported adverse events (FAERS/openFDA)#

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