Nighttime Sleep Aid

SPL v2

SPL

SPL Set ID 5d9658b0-99df-4851-a082-84e2e7ddc2c4

Route

ORAL

Published

Effective Date 2019-12-11

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

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-06-01

Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Warnings and Precautions

Warnings

Purpose

Nighttime sleep-aid

Description

Drug Facts

Use

for relief of occasional sleeplessness

Section 34088-5

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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 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: 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

Other Information

Store at 15°-30°C (59°-86°F)
Keep outer carton for complete warnings and product information

Inactive Ingredients

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

Questions Or Comments?

Call toll free: 1-800-833-6278

Principal Display Panel

Nighttime Sleep Aid 32ct Diphenhydramine HCl 50mg compare to the active ingredient in Unisom^® Sleep Gels^® NDC 51013-142-16

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

Structured Label Content

Use

for relief of occasional sleeplessness

Warnings and Precautions (34071-1)

Warnings

Section 34088-5 (34088-5)

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

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 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 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: 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

Other Information

Store at 15°-30°C (59°-86°F)
Keep outer carton for complete warnings and product information

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: 1-800-833-6278

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Nighttime Sleep Aid 32ct Diphenhydramine HCl 50mg compare to the active ingredient in Unisom^® Sleep Gels^® NDC 51013-142-16

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

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)

{"Use": "for relief of occasional sleeplessness", "34071-1": "Warnings", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center right away.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. ", "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", "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: 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", "Other Information": "Store at 15°-30°C (59°-86°F) Keep outer carton for complete warnings and product information ", "Inactive ingredients": "FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink", "Questions or comments?": "Call toll free: 1-800-833-6278", "PRINCIPAL DISPLAY PANEL": "Nighttime Sleep Aid 32ct Diphenhydramine HCl 50mg compare to the active ingredient in Unisom ® Sleep Gels ® NDC 51013-142-16", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:57.336768 · Updated: 2026-03-14T22:55:46.109144