Diphenhydramine Hydrochloride Capsules Usp 50 Mg

SPL v4

SPL

SPL Set ID 0e45d0e8-3741-7cee-e063-6394a90a2de5

Route

ORAL

Published

Effective Date 2026-01-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Polyethylene Glycol 600 Water Propylene Glycol Polyethylene Glycol 400 Sorbitol Fd&c Blue No. 1 Gelatin Glycerin

Identifiers & Packaging

Pill Appearance

Shape: capsule Color: blue Size: 13 mm

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-10

Description

(in each softgel) Diphenhydramine Hydrochloride USP 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

(in each softgel) Diphenhydramine Hydrochloride USP 50 mg

Uses

for relief of occasional sleeplessness

Warnings

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Directions

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

Active Ingredient

(in each softgel)

Diphenhydramine Hydrochloride USP 50 mg

Bulk Package Label

Inactive Ingredients

Propylene Glycol, Polyethylene Glycol 600, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Blue No.1, Purified Water

Principal Display Panel

Compare to the active ingredient Unisom ^® SleepGels ^®

SleepGels

NDC 35916-0438-1

Diphenhydramine Hydrochloride Capsules USP 50 mg

NIGHTTIME SLEEP-AID

♦ fall asleep fast ♦ sleep soundly

♦ safe, non-habit forming

100 SoftGels**

**liquid-filled capsules

one softgel per dose

When Using This Product

avoid alcoholic drinks

Stop Use and Ask A Doctor If

sleeplessness persist 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.

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

Uses

for relief of occasional sleeplessness

Purpose

Nighttime sleep-aid

Warnings

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Directions

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

Active Ingredient (Active ingredient)

(in each softgel)

Diphenhydramine Hydrochloride USP 50 mg

Bulk Package Label

Inactive Ingredients (Inactive ingredients)

Propylene Glycol, Polyethylene Glycol 600, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Blue No.1, Purified Water

Principal Display Panel

Compare to the active ingredient Unisom ^® SleepGels ^®

SleepGels

NDC 35916-0438-1

Diphenhydramine Hydrochloride Capsules USP 50 mg

NIGHTTIME SLEEP-AID

♦ fall asleep fast ♦ sleep soundly

♦ safe, non-habit forming

100 SoftGels**

**liquid-filled capsules

one softgel per dose

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 persist 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.

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": "POLYETHYLENE GLYCOL 600", "unii": "NL4J9F21N9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional sleeplessness", "Purpose": "Nighttime sleep-aid", "Warnings": "Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "Directions": "adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor", "Active ingredient": "(in each softgel) Diphenhydramine Hydrochloride USP 50 mg", "Inactive ingredients": "Propylene Glycol, Polyethylene Glycol 600, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Blue No.1, Purified Water", "Principal Display Panel": "Compare to the active ingredient Unisom ® SleepGels ® SleepGels NDC 35916-0438-1 Diphenhydramine Hydrochloride Capsules USP 50 mg NIGHTTIME SLEEP-AID ♦ fall asleep fast ♦ sleep soundly ♦ safe, non-habit forming 100 SoftGels** **liquid-filled capsules one softgel per dose", "When using this product": "avoid alcoholic drinks", "Stop use and ask a doctor if": "sleeplessness persist 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.", "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

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Source: dailymed · Ingested: 2026-02-15T12:08:22.020377 · Updated: 2026-03-14T23:12:35.594126