Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID 17639c3b-5d36-41f5-bd0d-da29075abd09

Route

ORAL

Published

Effective Date 2025-08-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2019-11-29 Until 2027-01-11

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

Maximum Strength Sleep-Aid

Other Information

store between 15°-30°C (59°-86°F)

Inactive Ingredients

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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Maximum Strength

Sleep-Aid

diphenhydramine HCl 50 mg

nighttime sleep-aid

softgels

One Softgel Per Dose

†Compare to the active ingredient in Unisom® SleepGels®

†This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®.

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

Distributed by: PL Developments

200 Hicks Street

Westbury, NY 11590

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 right away (1-800-222-1222)

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

Maximum Strength Sleep-Aid

Other Information (Other information)

store between 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Maximum Strength

Sleep-Aid

diphenhydramine HCl 50 mg

nighttime sleep-aid

softgels

One Softgel Per Dose

†Compare to the active ingredient in Unisom® SleepGels®

†This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®.

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

Distributed by: PL Developments

200 Hicks Street

Westbury, NY 11590

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 right away (1-800-222-1222)

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": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "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": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "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": "Maximum Strength Sleep-Aid", "Other information": "store between 15°-30°C (59°-86°F)", "Inactive ingredients": "FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, propylene, purified water, sorbitol, sorbitan, white ink", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "Maximum Strength Sleep-Aid diphenhydramine HCl 50 mg nighttime sleep-aid softgels One Softgel Per Dose †Compare to the active ingredient in Unisom® SleepGels® †This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by: PL Developments 200 Hicks Street Westbury, NY 11590", "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 right away (1-800-222-1222)", "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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:48.813616 · Updated: 2026-03-14T23:09:46.965889