Family Wellness 44-002A

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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed
• mL = milliliter
• only use the dose cup provided
• take only one dose per day (24 hours)
• adults and children 12 years and over: take 30 mL at bedtime if needed or as directed by a doctor
• children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

• each 30 mL contains: sodium 11 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY
Wellness™

*COMPARE TO THE ACTIVE
INGREDIENT IN VICKS®
ZzzQuil® NIGHTTIME
SLEEP-AID

NIGHTTIME
SLEEP
AID

Diphenhydramine HCl 50 mg
per 30 mL
Nighttime Sleep-Aid

• Non-habit forming
• Not for colds or for pain

12 FL OZ
(355 mL)

AGES
12 YEARS
& OVER

BERRY
FLAVORED

F-002A REV A

NDC 55319-802-45

Related RxNorm Concepts#

Product Linked Resources#

DailyMed Product Concepts#

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

• Nighttime Sleep Aid
• Diphenhydramine HCl
• DIPHENHYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE
• ANHYDROUS CITRIC ACID
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GLYCERIN
• HIGH FRUCTOSE CORN SYRUP
• PROPYLENE GLYCOL
• WATER
• SODIUM BENZOATE
• SODIUM CHLORIDE
• TRISODIUM CITRATE DIHYDRATE
• SUCRALOSE
• SUCROSE
• XANTHAN GUM

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

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.