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
Purpose

Nighttime sleep aid

Description

Diphenhydramine HCl 50mg

Medication Information

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

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 
Inactive Ingredients

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

Description

Diphenhydramine HCl 50mg

Principal Display Panel
Sleep Aid
Use(s)

for relief of occasional sleeplessness

Do Not Use
  • for children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin 
Questions/comments

Call1-888-952-0050 (Mon-Fri 9AM-5PM EST)

Active Ingredient(s)

Diphenhydramine HCl 50mg

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

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

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 
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel
Sleep Aid
Use(s)

for relief of occasional sleeplessness

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other products containing diphenhydramine, even one used on skin 
Questions/comments (Questions/Comments)

Call1-888-952-0050 (Mon-Fri 9AM-5PM EST)

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

Diphenhydramine HCl 50mg

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