410 - Sleep Aid

410 - Sleep Aid
SPL v2
SPL
SPL Set ID 2b730fa5-47f9-468d-86ed-0d49d9cd8dc4
Route
ORAL
Published
Effective Date 2023-07-06
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 2023-11-08
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: Take1 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 
  • do not use if imprinted safety seal under cap is broken or missing 
Questions/comments

Call1-888-952-0050 (Mon-Fri 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: Take1 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 
  • do not use if imprinted safety seal under cap is broken or missing 
Questions/comments (Questions/Comments)

Call1-888-952-0050 (Mon-Fri 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: 2026-02-15T12:02:17.408508 · Updated: 2026-03-14T23:01:45.300207