Cvs Health ™ - DailyMed Details

Cvs Health ™

SPL v9

SPL

SPL Set ID a575a914-14a0-442c-a504-ac7a0aa0ac77

Route

ORAL

Published

Effective Date 2025-12-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Potassium Citrate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-09-22

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 ifsleeplessness 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 aretaking sedatives or tranquilizers or any other sleep- aid.

Section 53414-9

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

Directions

take only one dose per day (24 hours) – see Overdose warning
measure with dosing cup provided

adults & children 12yrs & 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

Do Not Use

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

Other Information

each 30 mL dose contains: potassium 5 mg; sodium 10 mg
store at room temperature
protect from light. Does not meet USP <671>.

Overdose Warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Inactive Ingredients

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel

CVS Health™

NDC 59779-893-06

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

Alcohol Free

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCl

Non-habit forming

Not for treating cold or flu

Berry Flavor

Naturally and Artificially Flavored

6 FL OZ (177 mL)

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®

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com ^®1-800-SHOP CVS

V-30486

CVS® Quality

Money Back Guarantee

When Using This Product

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

Active Ingredient (in Each 30 Ml)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

a breathing problem such as asthma, emphysema, or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
heart disease

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 ifsleeplessness 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 aretaking sedatives or tranquilizers or any other sleep- aid.

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) – see Overdose warning
measure with dosing cup provided

adults & children 12yrs & 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

Do Not Use (Do not use)

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

Other Information (Other information)

each 30 mL dose contains: potassium 5 mg; sodium 10 mg
store at room temperature
protect from light. Does not meet USP <671>.

Overdose Warning: (Overdose warning:)

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CVS Health™

NDC 59779-893-06

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

Alcohol Free

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCl

Non-habit forming

Not for treating cold or flu

Berry Flavor

Naturally and Artificially Flavored

6 FL OZ (177 mL)

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®

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com ^®1-800-SHOP CVS

V-30486

CVS® Quality

Money Back Guarantee

When Using This Product (When using this product)

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

Active Ingredient (in Each 30 Ml) (Active ingredient (in each 30 mL))

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

a breathing problem such as asthma, emphysema, or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
heart disease

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CITRATE", "unii": "EE90ONI6FF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep- aid.", "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) – see Overdose warning measure with dosing cup provided adults & children 12yrs & 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", "Do not use": "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", "Other information": "each 30 mL dose contains: potassium 5 mg; sodium 10 mg store at room temperature protect from light. Does not meet USP <671>.", "Overdose warning:": "Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.", "Inactive ingredients": "anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.", "PRINCIPAL DISPLAY PANEL": "CVS Health™ NDC 59779-893-06 Compare to the active ingredient in ZzzQuil® Nighttime Sleep-Aid* Alcohol Free Nighttime Sleep-Aid DIPHENHYDRAMINE HCl Non-habit forming Not for treating cold or flu Berry Flavor Naturally and Artificially Flavored 6 FL OZ (177 mL) 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® Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2019CVS/pharmacy CVS.com ® 1-800-SHOP CVS V-30486 CVS® Quality Money Back Guarantee", "When using this product": "avoid alcoholic beverages and other drugs that cause drowsiness drowsiness will occur be careful when driving a motor vehicle or operating machinery", "Active ingredient (in each 30 mL)": "Diphenhydramine HCl 50 mg", "Ask a doctor before use if you have": "a breathing problem such as asthma, emphysema, or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland heart disease"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:34.106947 · Updated: 2026-03-14T23:11:10.262850