DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride capsule 
Preferred Pharmaceuticals, Inc.

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.

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Drug Facts

Active ingredient(in each capsule)

Diphenhydramine HCL 25 mg
Diphenhydramine HCL 50 mg

Purpose

Antihistamine

Uses:

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.
Sneezing.
Nasal congestion.
Runny nose.
Itchy, watery eyes.

Warnings:

Do not use

With any other product containing Diphenhydramine HCL, including one applied topically.

Ask a doctor or pharmacist before use

If you have

Trouble urinating due to enlarged prostate gland
A breathing problem such as emphysema or chronic bronchitis
Glaucoma
If you are taking sedatives or tranquilizers

When using this product

Avoid alcoholic drinks.
Marked drowsiness may occur.
Excitability may occur, especially in children.
Alcohol, sedatives and tranquilizers may increase drowsiness.
Be careful when driving a motor vehicle or operating machinery.

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 4-6 hours
Do not take more than 6 doses in 24 hours.

Adults and children 12 years or over

1 to 2 capsule                                     

Children 6 to under 12 years

1 capsule

Children under 6 years

ask a doctor

Other information:

Store at room temperature 15-30  degrees C (59-86 degrees F)
Protect from excessive moisture

Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

Diphenhydramine HCl Capsules, USP 25mg

Principal Display Panel

Diphenhydramine HCl Capsules, USP 50mg
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68788-9687(NDC:66424-020)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9687-010 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
2NDC:68788-9687-115 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
3NDC:68788-9687-330 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/27/2013
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68788-9688(NDC:66424-021)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9688-115 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
2NDC:68788-9688-330 in 1 BOTTLE, PLASTIC; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2010
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022REPACK(68788-9687, 68788-9688)

Revised: 11/2014
Document Id: 47be0d84-89b8-4e16-a87a-599d7e74467c
Set id: 3ac0beba-303d-404e-bfec-0cf8c0e8624d
Version: 2
Effective Time: 20141106
 
Preferred Pharmaceuticals, Inc.