Diphenhydramine Hydrochloride

Manufacturer
CVS PHARMACY, INC
Effective date
2023-03-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:34:36

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

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

Dosage and administration

■ take only one dose per day (24 hours) see overdose warning adults & children 12 years and over ■ 2 gelcaps at bedtime if needed or as directed by a doctor children under 12 years ■ do not use

Storage and handling

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature ■ avoid high humidity

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each gelcap)

Diphenhydramine HCl, USP 25 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

Do not use

WARNINGS 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ a breathing problem such as asthma, emphysema, or chronic bronchitis
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
■ heart disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking sedatives or tranquilizers or any other sleep-aid

When using this product

OTC - WHEN USING SECTION

■ avoid alcoholic beverages and other drugs that cause drowsiness
■ drowsiness will occur
■ be careful when driving a motor vehicle or operating 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 the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

Overdose warning

OVERDOSAGE SECTION

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ take only one dose per day (24 hours) see overdose warning

adults & children 12 years and over

■ 2 gelcaps at bedtime if needed or as directed by a doctor

children under 12 years

■ do not use

Other information

STORAGE AND HANDLING SECTION

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature
■ avoid high humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red # 28, D&C red # 33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6, gelatin, hydroxyl propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol,polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120 count120 count

FDA-Initiated Inactive NDC Indexing#

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-29969842-299-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
104338c2-d27c-5fe2-e063-6294a90adb6485796742-0de0-785f-e053-2a91aa0a04392024-01-31WarningsExact identifier
spl set id: 85796742-0de0-785f-e053-2a91aa0a0439

Reported adverse events (FAERS/openFDA)#

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