1019-qch-2024-0812

SPL v2

SPL

SPL Set ID 8d985ad7-71b9-493f-9b9a-d6ef280f72dd

Route

ORAL

Published

Effective Date 2024-08-12

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 Active Since 2024-08-12

Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

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 aretaking sedatives or tranquilizers

Section 53414-9

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

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

QUALITY CHOICE®

NDC 83324-110-32

†Compare to Active Ingredient in SOMINEX® Tablets

Nighttime Sleep Aid

Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

Does NOT Contain Pain Reliever

32 TABLETS

Actual Size

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

Structured Label Content

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 aretaking sedatives or tranquilizers

Section 53414-9 (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 (Do not use)

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

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)

QUALITY CHOICE®

NDC 83324-110-32

†Compare to Active Ingredient in SOMINEX® Tablets

Nighttime Sleep Aid

Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

Does NOT Contain Pain Reliever

32 TABLETS

Actual Size

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).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

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": "QUALITY CHOICE® NDC 83324-110-32 †Compare to Active Ingredient in SOMINEX® Tablets Nighttime Sleep Aid Diphenhydramine HCl 25 mg Nighttime Sleep-Aid Does NOT Contain Pain Reliever 32 TABLETS Actual Size", "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: 2026-02-15T12:03:24.869604 · Updated: 2026-03-14T23:03:28.306097