Sleep-aid

Sleep-aid
SPL v4
SPL
SPL Set ID 625d10db-925e-443d-b362-65c83f471746
Route
ORAL
Published
Effective Date 2024-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol 400 Propylene Glycol Povidone Sorbitol Solution Sorbitan Water

Identifiers & Packaging

Pill Appearance
Imprint: SD13 Shape: capsule Color: purple Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-27
Description

Drug Facts

Purpose

nighttime sleep-aid

Medication Information

Warnings and Precautions

Warnings

Purpose

nighttime sleep-aid

Description

Drug Facts

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.Overdose warning: Taking more than directed can cause serious health problems. 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 ifsleeplessness persists continuously 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 aretaking sedatives, tranquilizers or any other sleep aid

Section 53413-1

Distributed by:

Shield Pharmaceuticals Corp.

Hauppauge, NY 11788

Section 53414-9

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

Directions
  • do not take more than directed
  • take only one dose per day (24 hours)
adults & children 12 yrs & over take 2 capsules at bedtime if needed or as directed by a doctor
children under 12 years Do not use

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
Other Information
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • Protect from light
Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, propylene glycol, polyethylene glycol-400, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-800-373-6981

Principal Display Panel

SLEEP-AID

DIPHENHYDRAMINE HCl 25 mg

When Using This Product
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
Ask A Doctor Before Use If You Have
  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease
Active Ingredients (in Each Softgel)

Diphenhydramine HCl 25 mg

Structured Label Content

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.Overdose warning: Taking more than directed can cause serious health problems. 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 ifsleeplessness persists continuously 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 aretaking sedatives, tranquilizers or any other sleep aid

Section 53413-1 (53413-1)

Distributed by:

Shield Pharmaceuticals Corp.

Hauppauge, NY 11788

Section 53414-9 (53414-9)

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

Purpose

nighttime sleep-aid

Directions
  • do not take more than directed
  • take only one dose per day (24 hours)
adults & children 12 yrs & over take 2 capsules at bedtime if needed or as directed by a doctor
children under 12 years Do not use

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • Protect from light
Inactive Ingredients (Inactive ingredients)

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, propylene glycol, polyethylene glycol-400, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

1-800-373-6981

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SLEEP-AID

DIPHENHYDRAMINE HCl 25 mg

When Using This Product (When using this product)
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:05.361139 · Updated: 2026-03-14T23:13:21.652895