Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 566e40b1-e9d7-44e4-b971-eef2b7cf0a7d

Route

ORAL

Published

Effective Date 2018-12-26

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

Imprint: AZ247 Shape: round Color: blue Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-04-28

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 tablets at bedtime if needed or as directed by a doctor
Children under 12 years of age	do not use

Do Not Use

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

Active Ingredient

Diphenhydramine HCl 25 mg

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

When Using This Product

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

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. 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

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

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

Package/label Principal Display Panel

Diphenhydramine HCl 25mg

Ask A 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 tablets 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)

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

Active Ingredient (Active ingredient)

Diphenhydramine HCl 25 mg

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

When Using This Product (When using this product)

marked drowsiness may occur
avoid alcoholic beverages
do not drive a motor vehicle or operate 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 serious underlying medical illness.

If Pregnant Or Breast Feeding (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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

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

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

Diphenhydramine HCl 25mg

Ask A Doctor Or Pharmacist Before Use If You (Ask a 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 tablets at bedtime if needed or as directed by a doctor Children under 12 years of age do not use", "Do not use": "with any other products containing diphenhydramine, including one used on skin in children under 12 years of age", "Active ingredient": "Diphenhydramine HCl 25 mg", "Inactive Ingredients": "croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide ", "When using this product": "marked drowsiness may occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. 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": "In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.", "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", "Package/Label Principal Display Panel": "Diphenhydramine HCl 25mg", "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: 2026-02-15T12:02:20.709087 · Updated: 2026-03-14T23:01:49.492831