Nighttime Sleep Aid Caplets

Nighttime Sleep Aid Caplets
SPL v5
SPL
SPL Set ID 45ae6964-2a2b-4158-ba49-9ac642383460
Route
ORAL
Published
Effective Date 2021-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Fd&c Blue No. 1 Fd&c Blue No. 2 Lecithin, Soybean Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S5 Shape: capsule Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-28
Description

Drug Facts

Purpose

nighttime sleep-aid

Medication Information

Warnings and Precautions

Warnings

Purpose

nighttime sleep-aid

Description

Drug Facts

Uses

for the 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
  • for 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 25 mg

store between 20-25°C(68-77°F). Avoid high humidity. Protect from light.

Inactive Ingredients

Colloidal siicon dioxide, croscarmellose sodium, dicalcium phosphate, FD&C Blue#1, FD&C Blue#2, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principla Display Panel

Nighttime sleep-aid

Diphenhydramine HCI 25 mg - Nighttime Sleep-Aid



Does NOT contain pain reliever



Non-habit forming



36 Caplets

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 Ingredients (in Each Caplet)

Diphenhydramine HCl 25mg

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

Uses

for the relief of occasional sleeplessness

Warnings and Precautions (34071-1)

Warnings

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)
  • for 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 25 mg

store between 20-25°C(68-77°F). Avoid high humidity. Protect from light.

Inactive Ingredients (Inactive ingredients)

Colloidal siicon dioxide, croscarmellose sodium, dicalcium phosphate, FD&C Blue#1, FD&C Blue#2, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principla Display Panel (PRINCIPLA DISPLAY PANEL)

Nighttime sleep-aid

Diphenhydramine HCI 25 mg - Nighttime Sleep-Aid



Does NOT contain pain reliever



Non-habit forming



36 Caplets

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 Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Diphenhydramine HCl 25mg

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: 2026-02-15T12:04:48.327468 · Updated: 2026-03-14T23:05:48.377821