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Diphenhydramine Hydrochloride by NCS HealthCare of KY, Inc dba Vangard Labs

Medically reviewed on May 21, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-7656

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 Capsules 25mg

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 

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

• a breathing problem such as emphysema or chronic bronchitis

• glucoma

• trouble urinating due to an enlarged prostate gland 

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  1 to 2 capsules
children 6 to under 12 years of age1 capsule
children under 6 years of agedo not use this product in children under 6 years of age

Other information

• store at room temperature, see USP

• do not use if either capsule band or imprinted safety seal under cap is broken or missing

• protect from moisture

• contains lactose 

Inactive ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch 

Questions or comments?

(800) 616-2471 

Distributed by: MAJOR® PHARMACEUTICALS

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Livonia, MI 48150 USA

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DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7656(NDC:0904-5306)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
ANHYDROUS LACTOSE 
STARCH, CORN 
Product Characteristics
ColorPINK (White) Scoreno score
ShapeCAPSULESize4mm
FlavorImprint CodeCPC;835
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7656-3930 CAPSULE (30 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/02/2009
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-7656), REPACK(0615-7656)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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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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