sleep aid

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• in 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
• trouble urinating due to an enlarged prostate gland
• glaucoma

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over	take 2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years	do not use

Other information

STORAGE AND HANDLING SECTION

• each caplet contains: calcium 15 mg
• store at 20-25^°C (68-77^°F). Avoid high humidity. Protect from light.
• do not use if blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-habit forming

River

Sleep Aid

DIPHENHYDRAMINE HCl 25 mg

Nighttime Sleep Aid

24 CAPLETS

Does not contain pain reliever

Helps you fall asleep

Compare to Simply Sleep^® Nighttime Sleep Aid active ingredient

Actual Size

Related RxNorm Concepts#

FDA-Initiated Inactive NDC Indexing#

Products#

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

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

• sleep aid
• Diphenhydramine Hydrochloride
• DIPHENHYDRAMINE
• CARNAUBA WAX
• CROSPOVIDONE (15 MPA.S AT 5%)
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• FD&C BLUE NO. 1
• FD&C BLUE NO. 2
• HYPROMELLOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POLYSORBATE 80
• STEARIC ACID
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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.