Nighttime Sleep Aid

SPL v4

SPL

SPL Set ID ab825826-d911-4a0f-9d5c-5ee2f242b893

Route

ORAL

Published

Effective Date 2024-04-08

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 400 Propylene Glycol Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: SD28 Shape: capsule Color: blue Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-04-08

Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

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 (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

sleeplessness persist 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 useif you are taking sedatives or tranquilizers

Section 50569-3

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

Section 50570-1

Do not use

• for children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

Section 53414-9

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

uses

• for relief of occasional sleeplessness

Warnings

Directions

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

Other Information

• store at controlled room temperature 20-25ºC (68-77ºF)

• protect from light, heat and moisture

Inactive Ingredients

FD&C Blue #1, gelatin, glycerine, polyethylene glycol 400, propylene glycol, sorbitan

Questions Or Comments?

1-800-373-6981

Principal Display Panel

Compare to the active ingredient in Unisom® SleepGels

Sleep-Aid

Diphenhydramine HCI Softgels, 50 mg

Carton

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 50 mg

Structured Label Content

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 (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

sleeplessness persist 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 useif you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use

• for children under 12 years of age

• with any other product containing diphenhydramine, even one used on skin

Section 53414-9 (53414-9)

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

Purpose

Nighttime sleep-aid

uses (Uses)

• for relief of occasional sleeplessness

Warnings

Directions

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

Other Information (Other information)

• store at controlled room temperature 20-25ºC (68-77ºF)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C Blue #1, gelatin, glycerine, polyethylene glycol 400, propylene glycol, sorbitan

Questions Or Comments? (Questions or comments?)

1-800-373-6981

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredient in Unisom® SleepGels

Sleep-Aid

Diphenhydramine HCI Softgels, 50 mg

Carton

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

Diphenhydramine HCl 50 mg

Advanced Ingredient Data

[{"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 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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 (1-800-222-1222) right away.", "50566-9": "Stop use and ask a doctor if sleeplessness persist 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", "50569-3": "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", "50570-1": "Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nighttime sleep-aid", "Uses": "• 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", "Other information": "• store at controlled room temperature 20-25ºC (68-77ºF) • protect from light, heat and moisture", "Inactive ingredients": "FD&C Blue #1, gelatin, glycerine, polyethylene glycol 400, propylene glycol, sorbitan", "Questions or comments?": "1-800-373-6981", "PRINCIPAL DISPLAY PANEL": "Compare to the active ingredient in Unisom® SleepGels Sleep-Aid Diphenhydramine HCI Softgels, 50 mg Carton", "Active ingredient (in each softgel)": "Diphenhydramine HCl 50 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:06.785490 · Updated: 2026-03-14T23:13:21.652895