FDA Label for Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Active Ingredient (In Each Softgel)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Uses
- for the relief of occasional sleeplessness
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
When Using This Product
avoid alcoholic drinks
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"
* Please review the disclaimer below.