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
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