Healthy Accents Sleeptime

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 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
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
• with other Nighttime products

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 an 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
• drowsiness will occur
• do not drive a motor vehicle or operate machinery

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

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)

Directions

DOSAGE & ADMINISTRATION SECTION

• take only one dose per day (24 hours) – see Overdose warning

adults & children 12 yrs & over	2 softgels at bedtime if needed or as directed by a doctor
children under 12 yrs	do not use

Other information

STORAGE AND HANDLING SECTION

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-866-322-2439

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Vicks® ZzzQuil® Nighttime Sleep-aid active ingredient

sleeptime

nighttime sleep-aid

diphenhydramine HCl 25mg

non-habit forming

not for treating colds or the flu

see warnings

#1 Doctor Recommended Active Ingredient

actual size

NO GLUTEN

12 softgels

Related RxNorm Concepts#

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

• Healthy Accents Sleeptime
• Diphenhydramine HCl
• DIPHENHYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GELATIN
• GLYCERIN
• POLYETHYLENE GLYCOLS
• WATER

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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.