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DIPHENHYDRAMINE HYDROCHLORIDE by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Medically reviewed on August 27, 2018

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
NDC Code: 53345-007

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg capsule, liquid filled

Drug Facts

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

Warnings

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

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

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

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

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"

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-007
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
Coloryellow (clear) Scoreno score
ShapeCAPSULE (OBLONG) Size15mm
FlavorImprint CodePC4
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-007-011 BAG (BAG) in 1 BOX
120000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33609/15/2013
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-007), ANALYSIS(53345-007)

 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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