SPL v1
SPL
SPL Set ID b89c80aa-27ae-4fce-b574-8ee64bbae275
Route
ORAL
Published
Effective Date 2025-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Fd&c Blue No. 1 Aluminum Lake Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Magnesium Stearate Polyvinyl Alcohol Silicon Dioxide Stearic Acid Talc Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: 44;687 Shape: oval Color: blue Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01
Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Use

helps reduce difficulty falling asleep

Section 42229-5

Distributed by:

BI-MART

Eugene, OR 97402

Directions
  • adults and children 12 years of age and over: take 1 caplet at bedtime if needed, or as directed by your 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
  • with other antihistamines
Questions?

call toll free 1-844-912-4012

Other Information
  • each caplet contains:calcium 50 mg
  • store at room temperature
  • protect from moisture
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide

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 50 mg

Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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

helps reduce difficulty falling asleep

Section 42229-5 (42229-5)

Distributed by:

BI-MART

Eugene, OR 97402

Purpose

Nighttime sleep-aid

Directions
  • adults and children 12 years of age and over: take 1 caplet at bedtime if needed, or as directed by your 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
  • with other antihistamines
Questions?

call toll free 1-844-912-4012

Other Information (Other information)
  • each caplet contains:calcium 50 mg
  • store at room temperature
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, dicalcium calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide

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 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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: 2026-02-15T12:06:16.964920 · Updated: 2026-03-14T23:08:57.795400