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Diphenhydramine Hydrochloride Capsule, Liquid Filled

OTC Oral RxCUI 1049909
Contents

Overview

Active ingredient
Diphenhydramine Hydrochloride
Route
Oral
Label date
2026-01-07

Indications and usage

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

Purpose

Nighttime sleep-aid for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

Diphenhydramine HCl 25 mg

Dosage forms and strengths

take only one dose per day (24 hours) - see Overdose warning adults & Children 12 yrs & over One dose = TWO 25mg softgels (50mg) at bedtime if needed or as directed by a doctor

Warnings

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 do not use with NyQuil 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 taking sedatives or tranquilizers or any other sleep aid 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 sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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.

Do not use

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 do not use with NyQuil

Ask a doctor or pharmacist before use if

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 taking sedatives or tranquilizers or any other sleep aid

When using this product

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

and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Pregnancy or breast-feeding

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

Active ingredient (label)

Diphenhydramine HCl 25 mg Diphenhydramine HCl 25 mg

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Keep out of reach of children

of children. 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.