Sleep Aid

Sleep Aid
SPL v3
SPL
SPL Set ID 035454a1-d23b-4faf-8fac-a59fc77ce18c
Route
ORAL
Published
Effective Date 2018-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Carnauba Wax Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Oxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: DB Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-05-14
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.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9

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

Directions
adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years do not use
Do Not Use
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Other Information
  • each caplet contains: calcium 15 mg
  • store between 20-25 °C (68-77 °F). Avoid high humidity. Protect from light.
  • do not use if carton tape imprinted with "SAFETY SEAL®" is broken or missing or blister unit is torn or broken
Inactive Ingredients

carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

When Using This Product
  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
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.
Active Ingredient (in Each Caplet)

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

for relief of occasional sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking 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 and over take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years 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
Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Other Information (Other information)
  • each caplet contains: calcium 15 mg
  • store between 20-25 °C (68-77 °F). Avoid high humidity. Protect from light.
  • do not use if carton tape imprinted with "SAFETY SEAL®" is broken or missing or blister unit is torn or broken
Inactive Ingredients (Inactive ingredients)

carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Stop Use and Ask A Doctor If (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.
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)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.188734 · Updated: 2026-03-14T22:55:07.187033