1091-hyv-2025-1120

1091-hyv-2025-1120
SPL v2
SPL
SPL Set ID 3802d57e-7943-c0c2-e063-6394a90a7580
Route
oral
Published
Effective Date 2025-11-20
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 hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified titanium dioxide aluminum oxide

Identifiers & Packaging

Pill Appearance
Imprint: 25;052 Shape: oval Color: blue Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-11-20
Purpose

Nighttime sleep-aid

Description

Drug Facts

Medication Information

Purpose

Nighttime sleep-aid

Directions
adults and children 12 years of age and over take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age do not use
Other Information
  • each caplet contains:calcium 45 mg
  • store at room temperature 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 #1aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Description

Drug Facts

Principal Display Panel

NDC 61504-091-03

†COMPARE TO THE ACTIVE INGREDIENT IN SIMPLY SLEEP® CAPLETS

FIRST STREET®

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

Does not contain pain reliever

100 CAPLETS

ACTUAL SIZE

Use

for relief of 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 (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if

  • sleeplessness persists continously 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 50569-3

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
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
Questions Or Comments?

1-844-705-4384

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Structured Label Content

Purpose

Nighttime sleep-aid

Directions
adults and children 12 years of age and over take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of age do not use
Other Information (Other information)
  • each caplet contains:calcium 45 mg
  • store at room temperature 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 #1aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 61504-091-03

†COMPARE TO THE ACTIVE INGREDIENT IN SIMPLY SLEEP® CAPLETS

FIRST STREET®

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

Does not contain pain reliever

100 CAPLETS

ACTUAL SIZE

Use

for relief of 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 (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • sleeplessness persists continously 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 50569-3 (50569-3)

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
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
Questions Or Comments? (Questions or comments?)

1-844-705-4384

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

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:17.051827 · Updated: 2026-03-14T23:10:33.744870