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DIPHENHYDRAMINE HYDROCHLORIDE

Dosage form
CAPSULE, LIQUID FILLED
Labeler
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Label updated
2024-11-25
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses
  • for the relief of occasional sleeplessness
Warnings

Do not use

  • 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

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

Label information

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Label information

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

Label information

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

Label information

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by adoctor
Other information
  • store at 15°-30°C (59°-86°F)
Inactive ingredients

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

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei 430206,
China

PRINCIPAL DISPLAY PANEL - Shipping Label

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 50 mg

Quantity : 12000 Capsules
NDC. No : 53345-022-01

IMPORTANT:

Inspect immediately upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING"

[Image in the official label — see DailyMed source]

DailyMed Set ID: 50d74111-6d1b-4681-a264-f7e550320259 · Version 3
NDC: 53345-022