Kroger® Nighttime Sleep-aid

SPL v8

SPL

SPL Set ID 876eeb7c-75b8-8124-e053-2995a90ae922

Route

ORAL

Published

Effective Date 2019-04-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 602 Shape: capsule Color: purple Size: 15 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-04-25

Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Warnings and Precautions

Warnings

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. In care of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom be a symptom of serious underlying medical illness.

Section 50567-7

When using this product

avoid alcoholic beverages

Section 50568-5

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

Section 53413-1

Questions or comments? 1-800-632-6900

Section 53414-9

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

Directions

take only one dose per day (24 hours)

adults & children 12 years & over	One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
children under 12 years	Do not use

Do Not Use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin.

Other Information

Store at 20-25° C (68-77° F)
avoid excessive heat above 40° C (104° F)
Protect from light

Inactive Ingredients

FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

principal Display Panel

COMPARE TO the active ingredient of ZZZQUIL® *see side panel

NDC 30142-229-24

Kroger®

Nighttime Sleep-Aid

EZ Nite Sleep

Diphenhydramine HCL 25 mg

Helps Reduce Difficulty Faling Asleep

actual size

Non-Habit Forming

Not fro Treating Cold or Flu- See Warnings

24 SOFTGELS

*Zzzquil® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Comopany is not affiliated with The Kroger Co. ir this product.

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25mg

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 prostate gland

Structured Label Content

Uses

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In care of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom be a symptom of serious underlying medical illness.

Section 50567-7 (50567-7)

When using this product

avoid alcoholic beverages

Section 50568-5 (50568-5)

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

Section 53413-1 (53413-1)

Questions or comments? 1-800-632-6900

Section 53414-9 (53414-9)

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

Purpose

Nighttime sleep-aid

Directions

take only one dose per day (24 hours)

adults & children 12 years & over	One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
children under 12 years	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.

Other Information (Other information)

Store at 20-25° C (68-77° F)
avoid excessive heat above 40° C (104° F)
Protect from light

Inactive Ingredients (Inactive ingredients )

FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO the active ingredient of ZZZQUIL® *see side panel

NDC 30142-229-24

Kroger®

Nighttime Sleep-Aid

EZ Nite Sleep

Diphenhydramine HCL 25 mg

Helps Reduce Difficulty Faling Asleep

actual size

Non-Habit Forming

Not fro Treating Cold or Flu- See Warnings

24 SOFTGELS

*Zzzquil® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Comopany is not affiliated with The Kroger Co. ir this product.

Active Ingredient (in Each Softgel) (ACTIVE INGREDIENT (in each softgel))

Diphenhydramine HCl 25mg

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 prostate gland

Advanced Ingredient Data

[{"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": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "34071-1": "Warnings", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In care of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom be a symptom of serious underlying medical illness.", "50567-7": "When using this product avoid alcoholic beverages", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers ", "53413-1": "Questions or comments? 1-800-632-6900", "53414-9": "If pregnant of breast-feeding , ask a health professional before use.", "Purpose": "Nighttime sleep-aid", "Directions": "take only one dose per day (24 hours) adults & children 12 years & over One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor children under 12 years Do not use", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin.", "Other information": "Store at 20-25° C (68-77° F) avoid excessive heat above 40° C (104° F) Protect from light", "Inactive ingredients ": "FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "COMPARE TO the active ingredient of ZZZQUIL® *see side panel NDC 30142-229-24 Kroger® Nighttime Sleep-Aid EZ Nite Sleep Diphenhydramine HCL 25 mg Helps Reduce Difficulty Faling Asleep actual size Non-Habit Forming Not fro Treating Cold or Flu- See Warnings 24 SOFTGELS *Zzzquil® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Comopany is not affiliated with The Kroger Co. ir this product.", "ACTIVE INGREDIENT (in each softgel)": "Diphenhydramine HCl 25mg", "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 prostate gland"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:58.548876 · Updated: 2026-03-14T23:06:11.878508