1091-hyv-2026-0113

1091-hyv-2026-0113
SPL v2
SPL
SPL Set ID 462ca6cd-8eec-09df-e063-6294a90ac880
Route
ORAL
Published
Effective Date 2026-01-13
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 2026-01-13
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 (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.

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

Questions Or Comments?

1-844-705-4384

Principal Display Panel

HyVee®

NDC 42507-291-03

*Compare to the Active Ingredient in Simply Sleep® Caplets

Rest Simply

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Actual Size

100 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 (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.

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)
  • 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 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

Questions Or Comments? (Questions or comments?)

1-844-705-4384

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

HyVee®

NDC 42507-291-03

*Compare to the Active Ingredient in Simply Sleep® Caplets

Rest Simply

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Actual Size

100 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: 2026-02-15T12:08:13.325905 · Updated: 2026-03-14T23:12:23.079612