maximum strength sleep aid

maximum strength sleep aid
SPL v6
SPL
SPL Set ID cee5f4b1-613f-4e49-a29a-6d4c4bd5df18
Route
oral
Published
Effective Date 2020-07-02
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 400 propylene glycol sorbitol titanium dioxide water

Identifiers & Packaging

Pill Appearance
Imprint: 206;903 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-07-02
Purpose

Nighttime sleep-aid

Description

Drug Facts

Medication Information

Purpose

Nighttime sleep-aid

Directions
  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime, if needed, or as directed by a doctor
Inactive Ingredients

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Description

Drug Facts

Principal Display Panel

SLEEP AID

Diphenhydramine HCl 50 mg

100 Softgels

Use

for the relief of occasional sleeplessness

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

sleeplessness persist continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Section 50570-1

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. 

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Softgel)                           

Diphenhydramine HCl 50 mg

Structured Label Content

Purpose

Nighttime sleep-aid

Directions
  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime, if needed, or as directed by a doctor
Inactive Ingredients (Inactive ingredients)

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SLEEP AID

Diphenhydramine HCl 50 mg

100 Softgels

Use

for the relief of occasional sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

sleeplessness persist continuosly for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Section 50570-1 (50570-1)

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. 

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Active Ingredient (in Each Softgel)                            (Active ingredient (in each softgel)                           )

Diphenhydramine HCl 50 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:49.847041 · Updated: 2026-03-14T23:05:53.122655