Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID c0074c77-287e-6c26-e053-2995a90a4d31

Route

ORAL

Published

Effective Date 2022-12-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Glycerin Gelatin Lecithin, Soybean Water Sorbitan Medium-chain Triglycerides Titanium Dioxide Polyethylene Glycol, Unspecified Fd&c Blue No. 1 Hypromellose, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: P50 Shape: oval Color: blue Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-04-27

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Uses

■ for relief of occasional sleeplessness

■ reduces time to fall asleep if you have difficulty falling asleep

Section 42229-5

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

^†This product is not manufactured or distributed by the owners of Unisom ^®SleepGels ^®.

Made in USA using domestic and imported materials.

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

R0223 Lot No.: Exp. Date

L0000704

Directions

■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor.

■ swallow whole; do not crush, chew, or dissolve

Do Not Use

■ for children under 12 years of age

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

160's Count Label

^†Compare to the active ingredient in Unisom ^®SleepGels ^®

NDC 69452-322-79

a+health

maximum strength

nighttime

sleep-aid

diphenhydramine HCl capsules, 50 mg

• fall asleep fast

• sleep soundly

• safe, non-habit forming

160 softgels**

**liquid-filled capsules

one softgel per dose

Other Information

■ store at 20°C to 25°C (68°F to 77°F)

■ avoid high humidity and excessive heat above 40°C (104°F).

■ protect from light

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments?

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

When Using This Product

■ avoid alcoholic beverages

■ be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of 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 Centre right away.

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use

if you are taking sedatives or tranquilizers.

Structured Label Content

Uses

■ for relief of occasional sleeplessness

■ reduces time to fall asleep if you have difficulty falling asleep

Section 42229-5 (42229-5)

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

^†This product is not manufactured or distributed by the owners of Unisom ^®SleepGels ^®.

Made in USA using domestic and imported materials.

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

R0223 Lot No.: Exp. Date

L0000704

Purpose

Nighttime sleep-aid

Directions

■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor.

■ swallow whole; do not crush, chew, or dissolve

Do Not Use (Do not use)

■ for children under 12 years of age

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

160's Count Label (160's count Label)

^†Compare to the active ingredient in Unisom ^®SleepGels ^®

NDC 69452-322-79

a+health

maximum strength

nighttime

sleep-aid

diphenhydramine HCl capsules, 50 mg

• fall asleep fast

• sleep soundly

• safe, non-habit forming

160 softgels**

**liquid-filled capsules

one softgel per dose

Other Information (Other information)

■ store at 20°C to 25°C (68°F to 77°F)

■ avoid high humidity and excessive heat above 40°C (104°F).

■ protect from light

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

When Using This Product (When using this product)

■ avoid alcoholic beverages

■ be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of 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 Centre right away.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "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": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "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)

{"Uses": "■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep", "42229-5": "DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION ” IS BROKEN OR MISSING. † This product is not manufactured or distributed by the owners of Unisom ® SleepGels ® . Made in USA using domestic and imported materials. Manufactured for: Bionpharma Inc. Princeton, NJ 08540 R0223 Lot No.: Exp. Date L0000704", "Purpose": "Nighttime sleep-aid", "Directions": "■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor. ■ swallow whole; do not crush, chew, or dissolve", "Do not use": "■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.", "160's count Label": "† Compare to the active ingredient in Unisom ® SleepGels ® NDC 69452-322-79 a+health maximum strength nighttime sleep-aid diphenhydramine HCl capsules, 50 mg • fall asleep fast • sleep soundly • safe, non-habit forming 160 softgels** **liquid-filled capsules one softgel per dose", "Other information": "■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F). ■ protect from light", "Inactive ingredients": "FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide", "Questions or comments?": "call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)", "When using this product": "■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of 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 Centre right away.", "Active ingredient (in each capsule)": "Diphenhydramine HCl 50 mg", "Ask a doctor before use if you have": "■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the 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: 2026-02-15T12:02:35.433207 · Updated: 2026-03-14T23:02:13.859151