410 - Nighttime Sleep Aid

410 - Nighttime Sleep Aid
SPL v1
SPL
SPL Set ID c1481fad-9b32-4f84-8f03-4b4fa5edc866
Route
ORAL
Published
Effective Date 2024-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Water Sorbitol Solution

Identifiers & Packaging

Pill Appearance
Imprint: PC5 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-18
Description

Diphenhydramine HCl 50mg

Purpose

Nighttime sleep aid

Medication Information

Purpose

Nighttime sleep aid

Description

Diphenhydramine HCl 50mg

Use(s)
  • for relief of occasional sleeplessness
Directions

Adults and children 12 years and over: 1 softgel (50mg) at bedtime if needed, or as directed by a doctor

Do Not Use
  • for children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin  
Other Information
  • store at room temperature 15° to 30°C (59° to 86°F)
  • avoid excessive heat
Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST

Active Ingredient(s)

Diphenhydramine HCl 50mg

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Principal Display Panel
Sleep Aid
When Using This Product

avoid alcoholic drinks

Ask A Doctor Before Use If
  • a breathing problem such as emphysema or chronic bronchitis 
  • glaucoma 
  • trouble urinating due to an enlarged prostate gland
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 Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

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

Ask A Doctor Or Pharmacist Before Use If

you are taking sedatives or tranquilizers

Structured Label Content

Use(s)
  • for relief of occasional sleeplessness
Purpose

Nighttime sleep aid

Directions

Adults and children 12 years and over: 1 softgel (50mg) at bedtime if needed, or as directed by a doctor

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin  
Other Information (Other information)
  • store at room temperature 15° to 30°C (59° to 86°F)
  • avoid excessive heat
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST

Active Ingredient(s) (Active ingredient(s))

Diphenhydramine HCl 50mg

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Principal Display Panel
Sleep Aid
When Using This Product (When using this product)

avoid alcoholic drinks

Ask A Doctor Before Use If (Ask a doctor before use if)
  • a breathing problem such as emphysema or chronic bronchitis 
  • glaucoma 
  • trouble urinating due to an enlarged prostate gland
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 Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

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

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

Ask A Doctor Or Pharmacist Before Use If (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: 2026-02-15T12:03:10.968811 · Updated: 2026-03-14T23:03:06.131630