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DIPHENHYDRAMINE HYDROCHLORIDE by Contract Pharmacy Services-PA

Medically reviewed on August 30, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Contract Pharmacy Services-PA
NDC Code: 67046-124

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

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Diphenhydramine Hydrochloride 25 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

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Ask a doctor before use if you have

glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

Ask a doctor or pharmacist before use if you are

taking taking tranquilizers or sedative.

When using this product

you may get drowsy; 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. Do not use any other products containing diphenhydramine.

If pregnant or breast-feeding,

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. (1-800-222-1222

DIRECTIONS

Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours.

Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.

Children under 6 years of age: ask a doctor

OTHER INFORMATION

Store at controlled room temperature 59-86 degrees F.

INACTIVE INGREDIENTS

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate.

QUESTIONS OR COMMENTS?

Distributed by:

Qualitest Pharmaceuticals, Inc.

130 Vintage Drive

Huntsville, AL 35811

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--08/2010--NJW

Package Label

25 mg Capsules

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-124(NDC:0603-3339)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67046-124-3030 CAPSULE (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/30/2010
Labeler - Contract Pharmacy Services-PA (945429777)

 
Contract Pharmacy Services-PA

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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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