1019-bst-2021-1116

SPL v4

SPL

SPL Set ID d337a0e6-09ed-4db0-8883-ec8a5d56bd35

Route

oral

Published

Effective Date 2021-11-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (25 mg)

Inactive Ingredients

silicon dioxide croscarmellose sodium calcium phosphate, dibasic, anhydrous fd&c blue no. 1 aluminum oxide magnesium stearate cellulose, microcrystalline

Identifiers & Packaging

Pill Appearance

Imprint: 93XF;57344 Shape: round Color: blue Size: 10 mm Score: 1

Marketing Status

otc monograph drug completed Since 2017-01-19 Until 2027-12-31

Purpose

Nighttime sleep-aid

Description

Drug Facts

Medication Information

Active Ingredient

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over: take two tablets at bedtime if needed, or as directed by a doctor
children under 12 years of age: do not use

Other Information

each tablet contains: calcium 85 mg
store between 20-25°C (68-77°F)
retain carton for complete product information

Inactive Ingredients

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

Description

Drug Facts

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN SOMINEX®†

Best Choice®

ORIGINAL FORMULA

NIGHTTIME

Sleep-Aid

Actual Size

Diphenhydramine HCl

• Helps You Fall Asleep

• Safe, Effective & Non-Habit Forming

16 TABLETS

25 MG EACH

Use

helps to reduce difficulty falling asleep

Section 42229-5

Drug Facts

Section 50566-9

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.

Section 50567-7

When using this product

avoid alcoholic drinks
drowsiness will occur
do not drive a motor vehicle or operate machinery

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Do Not Use

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

Keep Out of Reach of Children.

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

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

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over: take two tablets at bedtime if needed, or as directed by a doctor
children under 12 years of age: do not use

Other Information (Other information)

each tablet contains: calcium 85 mg
store between 20-25°C (68-77°F)
retain carton for complete product information

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO THE ACTIVE INGREDIENT IN SOMINEX®†

Best Choice®

ORIGINAL FORMULA

NIGHTTIME

Sleep-Aid

Actual Size

Diphenhydramine HCl

• Helps You Fall Asleep

• Safe, Effective & Non-Habit Forming

16 TABLETS

25 MG EACH

Use

helps to reduce difficulty falling asleep

Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product

avoid alcoholic drinks
drowsiness will occur
do not drive a motor vehicle or operate machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Do Not Use (Do not use)

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

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 (1-800-222-1222).

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

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM OXIDE", "unii": "LMI26O6933", "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": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "helps to reduce difficulty falling asleep", "42229-5": "Drug Facts", "50566-9": "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.", "50567-7": "When using this product avoid alcoholic drinks drowsiness will occur do not drive a motor vehicle or operate machinery", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nighttime sleep-aid", "Directions": "adults and children 12 years of age and over: take two tablets 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 product containing diphenhydramine, even one used on skin", "Other information": "each tablet contains: calcium 85 mg store between 20-25°C (68-77°F) retain carton for complete product information", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose", "PRINCIPAL DISPLAY PANEL": "COMPARE TO THE ACTIVE INGREDIENT IN SOMINEX®† Best Choice® ORIGINAL FORMULA NIGHTTIME Sleep-Aid Actual Size Diphenhydramine HCl • Helps You Fall Asleep • Safe, Effective & Non-Habit Forming 16 TABLETS 25 MG EACH", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "Active ingredient (in each tablet)": "Diphenhydramine HCl 25 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.774020 · Updated: 2026-03-14T23:11:16.641314