1028-ddm-2025-0630

SPL v5

SPL

SPL Set ID e3f4d063-921d-4503-89a6-26cc9c46b4c9

Route

ORAL

Published

Effective Date 2025-06-30

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 Magnesium Stearate Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance

Imprint: 93;XF;57344 Shape: oval Color: white Size: 15 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2007-06-27 Until 2027-06-30

Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

Use

relieves occasional sleeplessness

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50567-7

When using this productavoid alcoholic drinks

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 caplets (50 mg) at bedtime if needed, or as directed by a doctor

Do Not Use

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

Other Information

each caplet contains: calcium 85 mg
store at room temperature 15°-30°C (59°-86°F)
retain carton for complete product information

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose

Principal Display Panel

DISCOUNT drug mart FOOD FAIR

NDC 53943-138-03

†Compare to the active ingredient in Nytol® QuickCaps®

Nyt-Time Sleep-Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Actual Size

72 Caplets

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

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

Structured Label Content

Use

relieves occasional sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsleeplessness 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 productavoid alcoholic drinks

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 caplets (50 mg) at bedtime if needed, or as directed by a doctor

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 caplet contains: calcium 85 mg
store at room temperature 15°-30°C (59°-86°F)
retain carton for complete product information

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

DISCOUNT drug mart FOOD FAIR

NDC 53943-138-03

†Compare to the active ingredient in Nytol® QuickCaps®

Nyt-Time Sleep-Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Actual Size

72 Caplets

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

Diphenhydramine HCl 25 mg

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

glaucoma
a breathing problem such as emphysema or chronic bronchitis
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": "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": "relieves occasional sleeplessness", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "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", "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 caplets (50 mg) at bedtime if needed, or as directed by a doctor", "Do not use": "in children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "Other information": "each caplet contains: calcium 85 mg store at room temperature 15°-30°C (59°-86°F) retain carton for complete product information", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose", "PRINCIPAL DISPLAY PANEL": "DISCOUNT drug mart FOOD FAIR NDC 53943-138-03 †Compare to the active ingredient in Nytol® QuickCaps® Nyt-Time Sleep-Aid Diphenhydramine HCl, 25 mg Nighttime Sleep-Aid Actual Size 72 Caplets", "Active ingredient (in each caplet)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:25.543336 · Updated: 2026-03-14T23:13:13.649161