Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID 0db543bb-c6c3-4370-a70c-e1652781fd7d

Route

ORAL

Published

Effective Date 2025-04-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin Glycerin Light Mineral Oil Polyethylene Glycol, Unspecified Water Sorbitan Sorbitol Lecithin, Soybean Mannitol

Identifiers & Packaging

Pill Appearance

Imprint: PC5 Shape: capsule Color: blue Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-03-26

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Use

for relief of occasional sleeplessness.

Directions

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Do Not Use

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

Package Label

KROGER HEALTH Nighttime Sleep-Aid

Other Information

store at 15-30°C (59°-86°F)

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink

Questions Or Comments?

1-800-632-6900

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN UNISOM SLEEPGELS®*

Nighttime Sleep-Aid

Diphenhydramine HCl 50 mg

Nighttime Sleep-Aid

FALL ASLEEP FAST,

SLEEP SOUNDLY,

WAKE REFRESHED

SOFTGELS

ONE SOFTGEL PER DOSE

*UNISOM SLEEPGELS® is a registered trademark of Chattem, Inc.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

When Using This Product

avoid alcoholic drinks.

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Use

for relief of occasional sleeplessness.

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Do Not Use (Do not use)

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

Package Label

KROGER HEALTH Nighttime Sleep-Aid

Other Information (Other information)

store at 15-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink

Questions Or Comments? (Questions or comments?)

1-800-632-6900

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN UNISOM SLEEPGELS®*

Nighttime Sleep-Aid

Diphenhydramine HCl 50 mg

Nighttime Sleep-Aid

FALL ASLEEP FAST,

SLEEP SOUNDLY,

WAKE REFRESHED

SOFTGELS

ONE SOFTGEL PER DOSE

*UNISOM SLEEPGELS® is a registered trademark of Chattem, Inc.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

When Using This Product (When using this product)

avoid alcoholic drinks.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

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 emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "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": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional sleeplessness.", "Purpose": "Nighttime sleep-aid", "Directions": "adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "Package Label": "KROGER HEALTH Nighttime Sleep-Aid", "Other information": "store at 15-30°C (59°-86°F)", "Inactive ingredients": "FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink", "Questions or comments?": "1- 800-632-6900", "Principal Display Panel": "COMPARE TO THE ACTIVE INGREDIENT IN UNISOM SLEEPGELS®* Nighttime Sleep-Aid Diphenhydramine HCl 50 mg Nighttime Sleep-Aid FALL ASLEEP FAST, SLEEP SOUNDLY, WAKE REFRESHED SOFTGELS ONE SOFTGEL PER DOSE *UNISOM SLEEPGELS® is a registered trademark of Chattem, Inc. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202", "When using this product": "avoid alcoholic drinks.", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Active ingredient (in each softgel)": "Diphenhydramine HCl 50 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:02.337723 · Updated: 2026-03-14T23:08:30.723878