cvs health™

cvs health™
SPL v1
SPL
SPL Set ID 03f521f4-d35f-4f66-b3ad-7e58a244eb93
Route
oral
Published
Effective Date 2017-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (50 mg)
Inactive Ingredients
anhydrous citric acid glycerin potassium citrate water sodium benzoate sorbitol sucralose xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2017-10-11
Purpose

Nighttime sleep-aid

Description

Drug Facts

Medication Information

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

Nighttime sleep-aid

Directions
  • •
    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
  • •
    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

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

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50568-5

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Do Not Use
  • •
    for children under 12 years of age
  • •
    with any other product containing diphenhydramine, even one used on skin
Active Ingredient

Diphenhydramine HCl 50 mg

Questions Or Comments?

1-866-467-2748

When Using This Product
  • •
    avoid alcoholic beverages
Ask A Doctor Before Use If You Have
  • •
    a breathing problem such as emphysema, or chronic bronchitis
  • •
    glaucoma
  • •
    difficulty in urination due to enlargement of the prostate gland

Structured Label Content

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

Nighttime sleep-aid

Directions
  • •
    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 (Other information)
  • •
    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 ingredients)

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

Principal Display Panel (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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Do Not Use (Do not use)
  • •
    for children under 12 years of age
  • •
    with any other product containing diphenhydramine, even one used on skin
Active Ingredient (Active ingredient)

Diphenhydramine HCl 50 mg

Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)
  • •
    avoid alcoholic beverages
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • •
    a breathing problem such as emphysema, or chronic bronchitis
  • •
    glaucoma
  • •
    difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:25.514110 · Updated: 2026-03-14T22:54:52.931560