Diphenhydramine Hcl 50mg Softgels

Diphenhydramine Hcl 50mg Softgels
SPL v5
SPL
SPL Set ID af0b1b08-e269-6399-e053-2a95a90ac12d
Route
ORAL
Published
Effective Date 2020-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Water Sorbitol Glycerin Gelatin Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: PC13 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-21
Description

Diphenhydramine HCl 50mg

Medication Information

Indications and Usage

for relied of occasional sleeplessness

Dosage and Administration

Dipheyhydramine HCl 50mg

Description

Diphenhydramine HCl 50mg

Use

For relief of occasional sleeplessness

Section 50565-1

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

Section 50570-1

for children under 12 years of age

with any other products containing diphenhydramine, even one used on skin

Section 51727-6

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Section 51945-4

RxZell

SleepAid

Dyphenhydramine HCl 50mg

Non Habit-Forming

Easy to Swallow

Section 55106-9

Diphenhydramine HCl 50mg

Direction

adults and children 12 years and over: 1 softgel at bedtime if needed, or as directed by a doctor

When Using This Product

avoid alcholic drinks

Stop Use and Ask A Doctor If

sleeplessness presists continuously for more than 2 weeks. Insomnic may be a symptom of a series underlying medical illness

If Pregnant Or Breast Feeding

ask a health professional before use

Package.label Principal Display Panel

Ask A Doctor Or Pharmacist Before Use If

you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, trouble urinating due to an enlarged prostate gland

you are taking sedatives or tranquilizers

Structured Label Content

Use

For relief of occasional sleeplessness

Indications and Usage (34067-9)

for relied of occasional sleeplessness

Dosage and Administration (34068-7)

Dipheyhydramine HCl 50mg

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

for children under 12 years of age

with any other products containing diphenhydramine, even one used on skin

Section 51727-6 (51727-6)

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

Section 51945-4 (51945-4)

RxZell

SleepAid

Dyphenhydramine HCl 50mg

Non Habit-Forming

Easy to Swallow

Section 55106-9 (55106-9)

Diphenhydramine HCl 50mg

Direction

adults and children 12 years and over: 1 softgel at bedtime if needed, or as directed by a doctor

When Using This Product (When using this product)

avoid alcholic drinks

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness presists continuously for more than 2 weeks. Insomnic may be a symptom of a series underlying medical illness

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

Package.label Principal Display Panel (Package.Label Principal Display Panel)

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, trouble urinating due to an enlarged prostate gland

you are taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:08.884087 · Updated: 2026-03-14T23:12:17.704012