Nighttime Sleep-aid

SPL v3

SPL

SPL Set ID 2b1af499-623e-4f6a-949b-21abf276b65d

Route

ORAL

Published

Effective Date 2019-11-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Water Sorbitol

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-10-31

Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Uses

for the relief of occasional sleeplessness

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case 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 continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7

When using this product avoid alcoholic drinks

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

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

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 15°-30°C (59°-86°F)

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments?

Call toll free 1-888-287-1915

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

Principal Display Panel 96ct Bottle Label

Nighttime Sleep-Aid Maximum Strength

Diphenhydramine HCl, 50 mg 96 Softgels

Compare to Unisom^® SleepGels^® Active Ingredient^*

NDC 49035-237-96

Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716

^*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom^® SleepGels^®

Principal Display Panel 32ct Carton and Bottle Label

Nighttime Sleep-Aid Maximum Strength

Diphenhydramine HCl, 50 mg 32 Softgels

Compare to Unisom® SleepGels^® Active Ingredient^*

NDC 49035-237-16

Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716

^*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom^® SleepGels^®

Structured Label Content

Uses

for the relief of occasional sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case 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 continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7 (50567-7)

When using this product avoid alcoholic drinks

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

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

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 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-287-1915

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

Principal Display Panel 96ct Bottle Label (PRINCIPAL DISPLAY PANEL - 96ct Bottle Label)

Nighttime Sleep-Aid Maximum Strength

Diphenhydramine HCl, 50 mg 96 Softgels

Compare to Unisom^® SleepGels^® Active Ingredient^*

NDC 49035-237-96

Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716

^*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom^® SleepGels^®

Principal Display Panel 32ct Carton and Bottle Label (PRINCIPAL DISPLAY PANEL - 32ct Carton and Bottle Label)

Nighttime Sleep-Aid Maximum Strength

Diphenhydramine HCl, 50 mg 32 Softgels

Compare to Unisom® SleepGels^® Active Ingredient^*

NDC 49035-237-16

Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716

^*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom^® SleepGels^®

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": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of occasional sleeplessness", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "50567-7": "When using this product avoid alcoholic drinks", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nighttime sleep-aid", "Directions": "adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by adoctor", "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 15°-30°C (59°-86°F)", "Inactive ingredients": "FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink", "Questions or comments?": "Call toll free 1-888-287-1915", "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", "PRINCIPAL DISPLAY PANEL - 96ct Bottle Label": "Nighttime Sleep-Aid Maximum Strength Diphenhydramine HCl, 50 mg 96 Softgels Compare to Unisom ® SleepGels ® Active Ingredient * NDC 49035-237-96 Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716 * This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ® SleepGels ®", "PRINCIPAL DISPLAY PANEL - 32ct Carton and Bottle Label": "Nighttime Sleep-Aid Maximum Strength Diphenhydramine HCl, 50 mg 32 Softgels Compare to Unisom® SleepGels ® Active Ingredient * NDC 49035-237-16 Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716 * This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ® SleepGels ®"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:55.766412 · Updated: 2026-03-14T22:55:43.865902