Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 59c063ad-6ea3-4f1d-a20e-5e5e062a9098

Route

ORAL

Published

Effective Date 2026-02-10

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 2021-03-26 Until 2027-03-26

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

READYinCASE 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, purified water, sorbitol sorbitan, white ink

Questions Or Comments?

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

Principal Display Panel

†Compare to the active ingredient in Unisom® SleepGels®

Sleep Aid

Diphenhydramine HCl, 50 mg

Nighttime Sleep-Aid

Fall Asleep Fast
Sleep Soundly
Wake Up Refreshed

non-habit-forming

softgels

One Softgel Per Dose

†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

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:

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 (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

READYinCASE 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, 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

†Compare to the active ingredient in Unisom® SleepGels®

Sleep Aid

Diphenhydramine HCl, 50 mg

Nighttime Sleep-Aid

Fall Asleep Fast
Sleep Soundly
Wake Up Refreshed

non-habit-forming

softgels

One Softgel Per Dose

†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

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:

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 (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": "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": "READYinCASE 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, purified water, sorbitol sorbitan, white ink", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "†Compare to the active ingredient in Unisom® SleepGels ® Sleep Aid Diphenhydramine HCl, 50 mg Nighttime Sleep-Aid Fall Asleep Fast Sleep Soundly Wake Up Refreshed non-habit-forming softgels One Softgel Per Dose †This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®. 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: 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 (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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:37.511164 · Updated: 2026-03-14T23:12:55.175782