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DIPHENHYDRAMINE HYDROCHLORIDE

Dosage form
CAPSULE, LIQUID FILLED
Labeler
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Label updated
2024-11-20
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses
  • for the relief of occasional sleeplessness
Warnings

Label information

  • do not give to children under 12 years of age
  • do not usewith any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • a breathing problem such as 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.

Label information

When using this productavoid alcoholic drinks.

Stop use and ask a doctor if

  • sleeplessness persist 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:1 softgel (50 mg) at bedtime if needed, or as directed by a doctor.
Other information
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • do not use if imprinted safety seal under cap is broken or missing
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 : 53345-005-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

PRINCIPAL DISPLAY PANEL - Shipping Label

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 50 mg

Quantity : 80 Bottles
NDC. No : 53345-005-02

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

[Image in the official label — see DailyMed source]

DailyMed Set ID: f8de6605-4a0a-492d-beb5-f414ce8bfb0e · Version 10
NDC: 53345-005