WINCO

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL dose cup)

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

• avoid alcoholic beverages

OTC - STOP USE SECTION

Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning:

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

adults & children 12yrs & 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 dose contains: potassium 5 mg, sodium 10 mg
• store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67091-630-06

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

Nighttime Sleep-Aid

Diphenhydramine HCl

Non-Habit Forming

Makes you fall asleep fast

BERRY FLAVOR

Naturally and Artificially Flavored

No added alcohol

Not for Pain. Not for Colds.

Just for Sleep

6 FL OZ (177 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

Related RxNorm Concepts#

DailyMed Product Concepts#

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

• Nighttime Sleep Aid Berry Flavor
• DIPHENHYDRAMINE HYDROCHLORIDE
• DIPHENHYDRAMINE
• ANHYDROUS CITRIC ACID
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GLYCERIN
• POTASSIUM CITRATE
• WATER
• SODIUM BENZOATE
• SORBITOL
• SUCRALOSE
• XANTHAN GUM

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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.