Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID dbbc535f-515a-4d9b-b799-34e60f5230bb

Route

ORAL

Published

Effective Date 2018-12-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 1 Hypromelloses Lactose, Unspecified Form Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Shape: capsule Color: blue Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-03-03

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Medication Information

Purpose

Nighttime sleep aid

Description

Diphenhydramine HCl 25 mg

Uses

relief of occasional sleeplessness

Directions

adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

children under 12 years of age: do not use

Do Not Use

in children under 12 years of age
with any other products containing diphenhydramine, including ones used on skin

Other Information

store at room temperature store between 20-25°C (68-77°F)
do not use if blister unit is torn or open

Inactive Ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

When Using This Product

avoid alcoholic beverages
drowsiness may occur
do not drive a motor vehicle or operating machinery

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.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

If Pregnancy Or Breast Feeding

ask a health professional before use.

Ask Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Package/label Principal Display Panel

Sleep Aid

Ask Doctor Or Pharmacist Before Use If You

are taking sedatives or tranquilizers

Structured Label Content

Uses

relief of occasional sleeplessness

Purpose

Nighttime sleep aid

Directions

adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

children under 12 years of age: do not use

Do Not Use (Do not use)

in children under 12 years of age
with any other products containing diphenhydramine, including ones used on skin

Other Information (Other information)

store at room temperature store between 20-25°C (68-77°F)
do not use if blister unit is torn or open

Inactive Ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

When Using This Product (When using this product)

avoid alcoholic beverages
drowsiness may occur
do not drive 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. Insomnia may be a symptom of a serious underlying medical illness.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

If Pregnancy Or Breast Feeding (If pregnancy or breast-feeding)

ask a health professional before use.

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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Sleep Aid

Ask Doctor Or Pharmacist Before Use If You (Ask Doctor or Pharmacist before use if you)

are taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relief of occasional sleeplessness", "Purpose": "Nighttime sleep aid", "Directions": "adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age: do not use", "Do not use": "in children under 12 years of age with any other products containing diphenhydramine, including ones used on skin ", "Other information": "store at room temperature store between 20-25°C (68-77°F) do not use if blister unit is torn or open", "Inactive Ingredients": "croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide", "When using this product": "avoid alcoholic beverages drowsiness may occur do not drive a motor vehicle or operating machinery ", "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.", "Keep Out of Reach of Children": "In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. ", "If pregnancy or breast-feeding": "ask a health professional before use.", "Ask doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "Active ingredient (in each caplet)": "Diphenhydramine HCl 25 mg", "Package/Label Principal Display Panel": " Sleep Aid", "Ask 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: 2026-02-15T12:06:07.546994 · Updated: 2026-03-14T23:08:44.584027