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
Description

Drug Facts

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Drug Facts

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. 

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

Questions Or Comments?

1-888-333-9792

Principal Display Panel

SLEEP AID

Diphenhydramine HCl 50 mg

100 Softgels

Active Ingredient (in Each Softgel)                           

Diphenhydramine HCl 50 mg

Structured Label Content

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. 

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

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SLEEP AID

Diphenhydramine HCl 50 mg

100 Softgels

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