SPL v1
SPL
SPL Set ID e5146569-a42b-43f8-a3d1-4f7bcdaef6f7
Route
ORAL
Published
Effective Date 2025-06-08
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 Magnesium Stearate Cellulose, Microcrystalline Titanium Dioxide Polyvinyl Alcohol Polyethylene Glycol, Unspecified Talc Stearic Acid Fd&c Blue No. 1 Fd&c Blue No. 2

Identifiers & Packaging

Pill Appearance
Imprint: S25 Shape: capsule Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01
Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Use

help reduce difficult falling asleep

Section 42229-5

Distributed by:

BI-MART

Eugene, OR 97402

Warnings

Directions
  • adults and children 12 years of age and older: take 2 caplets at bedtime if needed or as directed by a doctor
Do Not Use
  • in children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin
  • with other antihistamines
Questions?

Call toll-free 1-844-912-4012

Other Information
  • each caplet contains:calcium 30 mg

  • each caplet contains:phosphorus 15 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

Inactive Ingredients

Briliant Blue Lack, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Indigo Carmine Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, Titanium Dioxide

Principal Display Panel

When Using This Product
  • avoid alcoholic beverages
  • be careful when driveing a motor vehicle or operating machinery
Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

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
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Use

help reduce difficult falling asleep

Section 42229-5 (42229-5)

Distributed by:

BI-MART

Eugene, OR 97402

Purpose

Nighttime sleep-aid

Warnings

Directions
  • adults and children 12 years of age and older: take 2 caplets at bedtime if needed or as directed by a doctor
Do Not Use (Do not use)
  • in children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin
  • with other antihistamines
Questions?

Call toll-free 1-844-912-4012

Other Information
  • each caplet contains:calcium 30 mg

  • each caplet contains:phosphorus 15 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

Inactive Ingredients

Briliant Blue Lack, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Indigo Carmine Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, Titanium Dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • avoid alcoholic beverages
  • be careful when driveing a motor vehicle or operating 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 a serious underlying medical illness.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.804905 · Updated: 2026-03-14T23:08:57.795400