410-sleep aid diphenhydramine hcl 50mg

410-sleep aid diphenhydramine hcl 50mg
SPL v8
SPL
SPL Set ID ec57db48-0f3a-4b12-8633-b45a4366c269
Route
oral
Published
Effective Date 2020-11-06
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
Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-11-09
Purpose

Nighttime sleep aid

Description

Diphenhydramine HCl 50mg

Medication Information

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

Other Information
  • do not use if imprinted safety seal under cap is broken or missing or
  • do not use if blister unit is torn or open

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

Storage

store at room temperature 15° to 30°C (59° to 86°F) and avoid excessive heat  

Do Not Use

for children under 12 years of age 

  • with any other products containing diphenhydramine, even one used on skin  

Active Ingredient(s)

Diphenhydramine HCl 50mg

Pregnancy/breastfeeding

ask a health professional before use.

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.

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: 1 softgel (50mg) at bedtime if needed, or as directed by a doctor

Other Information (Other information)
  • do not use if imprinted safety seal under cap is broken or missing or
  • do not use if blister unit is torn or open

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

Storage

store at room temperature 15° to 30°C (59° to 86°F) and avoid excessive heat  

Do Not Use (Do not use)

for children under 12 years of age 

  • with any other products containing diphenhydramine, even one used on skin  

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

Diphenhydramine HCl 50mg

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

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.

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:03.764834 · Updated: 2026-03-14T23:10:14.816739