FDA.reportPublic FDA data

CVS Health Nighttime Sleep Aid

Manufacturer
CVS Pharmacy,Inc.
Effective date
2017-10-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:42

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) • Measure with dosing cup provided   adults & children 12 yrs & over   One Dose = 30 mL 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: sodium 23 mg • store at room temperature • protect from light. Does not meet USP requirements for light-resistant packaging

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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages

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.

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only one dose per day (24 hours)
  • Measure with dosing cup provided
  • adults & children 12 yrs & over
  • One Dose = 30 mL 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: sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP requirements for light-resistant packaging

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health™

Compare to the active ingredient in ZzzQuil® Nighttime Sleep-Aid

NDC 69842-753-12

Alcohol Free

Nighttime

Sleep-Aid

Diphenhydramine HCl, 50 mg

Non – habit forming

DYE FREE

BERRY FLAVOR

12 FL OZ (354 mL)

SEE NEW WARNINGS.

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 Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

DISTRIBUTED BY: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2018 CVS/ Pharmacy

CVS .com® 1-800-SHOP CVS

CVS Quality Money Back Guarantee

CVS Health Nighttime Sleep-Aid Diphenhydramine HCl 50 mg 12 FL OZ
CVS Health Nighttime Sleep-Aid Diphenhydramine HCl 50 mg 12 FL OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN1
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD1
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY1
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428594568GTIN-13: 0050428594568
EAN-13: 0050428594568
GTIN-12: 050428594568
UPC-A: 050428594568
GTIN storage (14 digits): 00050428594568		image-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-753-12CVS Health Nighttime Sleep Aid354 mL in 1 BOTTLE, PLASTICLIQUID3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-753CVS HEALTH NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]1Current NDC, Legacy NDC, 1 package rows20171018_03f521f4-d35f-4f66-b3ad-7e58a244eb93.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-75369842-753-12

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CITRATEEE90ONI6FFIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

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
CVS Health Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.03f521f4-d35f-4f66-b3ad-7e58a244eb932017-10-18WarningsExact identifier
ndc (package): 69842-753-12
ndc (product): 69842-753
ndc11 (package): 69842075312
spl id: 03f521f4-d35f-4f66-b3ad-7e58a244eb93
spl set id: 03f521f4-d35f-4f66-b3ad-7e58a244eb93

Reported adverse events (FAERS/openFDA)#

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