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DIPHENDYDRAMINE HYDROCHLORIDE by NCS HealthCare of KY, Inc dba Vangard Labs

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-7657

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.

Diphendydramine Hydrochloride Capsules

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Diphenhydramine Hydrochloride 50 mg

PURPOSE

Antihistamine

USES

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

WARNINGS

Do not use

• with any other products containing diphenhydramine including one applied topically 

Ask a doctor before use if you have

• glaucoma

• a breathing problem such as emphysema or chronic bronchitis

• difficulty in urination due to enlargement of the prostate gland.

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

When using this product

• marked drowsiness may occur

• avoid alcoholic drinks

• alcohol, sedatives and tranquilizers may increase drowsiness

• use caution 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

Adults and children 12 years and over: take 1 capsule (50mg) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 12 years: ask a doctor, the proper dosage strength is not available in this package

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25mg package.

OTHER INFORMATION

• store at controlled room temperature. USP

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

• protect from excessive moisture

• use by expiration date on package

• contains lactose

INACTIVE INGREDIENTS

D&C red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose and starch.

QUESTIONS?

Adverse drug event call: (800) 616-2471

Distributed by:

Major® Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA M-29

R 12/09

PRINCIPAL DISPLAY PANEL

DIPHENDYDRAMINE HYDROCHLORIDE 
diphendydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7657(NDC:0904-5307)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
GELATIN 
D&C RED NO. 28 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
STARCH, CORN 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize4mm
FlavorImprint Codecpc;836
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7657-3930 CAPSULE (30 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33601/02/2009
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-7657), REPACK(0615-7657)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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Medically reviewed on May 7, 2018

Further information

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

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