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
Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

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

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
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

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.

Questions Or Comments?

1-866-467-2748

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

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
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.

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
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

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.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

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

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

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