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Drug Facts
Diphenhydramine Hydrochloride Capsule, Liquid Filled
FDA Label NDC 53345-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceutical (wuhan), Ltd. for the product Diphenhydramine Hydrochloride (NDC 53345-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each softgel), purpose, uses, do not use, ask a doctor before use if you have, when using this product, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
When Using This Product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
adults and children 12 years of age and over | take 1 to 2 softgels |
children 6 to under 12 years of age | take 1 softgel |
children under 6 years | do not use this product in children under 6 years of age |
Other Information
- store at room temperature 15°-30°C (59°-86°F)
- protect from heat, humidity, and light
Inactive Ingredients
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, 25 mg
Quantity : 20000 Capsules
NDC. No : 53345-007-01
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"
* Please review the disclaimer below.
