Leader Sleep Aid

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

• avoid alcoholic beverages

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• take only one dose per day (24 hours)
• only use the dose cup provided

adults & children 12 yrs & over	30 mL at bed time if needed or as directed by a doctor
children under 12 yrs	do not use

Other information

STORAGE AND HANDLING SECTION

• each 30 mL contains: sodium 20 mg
• store at 20-25^°C (68-77^°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleep Aid

Diphenhydramine HCl 50 mg

Nighttime Sleep-Aid

10% ALCOHOL

COMPARE TO ZzzQUIL® NIGHTTIME SLEEP-AID active ingredient

Berry Flavor

Not for Treating Cold or Flu

100% Money Back Guarantee

Non-Habit Forming

6 FL OZ (177mL)

186E9-sleep-aid-image2.jpg

Related RxNorm Concepts#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

• Leader Sleep Aid
• Diphenhydramine HCl
• DIPHENHYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE
• ALCOHOL
• ANHYDROUS CITRIC ACID
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• HIGH FRUCTOSE CORN SYRUP
• POLOXAMER 407
• PROPYLENE GLYCOL
• WATER
• SACCHARIN SODIUM
• SODIUM BENZOATE
• SODIUM CITRATE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.