Hte - 1091 - 2025-0520

Hte - 1091 - 2025-0520
SPL v4
SPL
SPL Set ID 2364f152-657e-4849-96b1-b51b3c77bf86
Route
ORAL
Published
Effective Date 2025-05-20
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 Hypromellose, Unspecified Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 25;052 Shape: oval Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-10-06
Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

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.

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 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.

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
Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
Other Information
  • each caplet contains: calcium 45 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, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments?

1-844-705-4384

Principal Display Panel

Harris Teeter™

NDC 72036-091-01

Rest Simply

†Compare to the Active Ingredient in Simply Sleep®

Diphenhydramine HCl, 25 mg

NIGHTTIME SLEEP-AID

• Helps you fall asleep

Actual Size

24 CAPLETS

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Structured Label Content

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.

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 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.

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
Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
Other Information (Other information)
  • each caplet contains: calcium 45 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, FD&C blue #1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-844-705-4384

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Harris Teeter™

NDC 72036-091-01

Rest Simply

†Compare to the Active Ingredient in Simply Sleep®

Diphenhydramine HCl, 25 mg

NIGHTTIME SLEEP-AID

• Helps you fall asleep

Actual Size

24 CAPLETS

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

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Source: dailymed · Ingested: 2026-02-15T12:06:09.371330 · Updated: 2026-03-14T23:08:46.104923