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 Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9687(NDC:66424-020)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
Color pink Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code PH014
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9687-0 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:68788-9687-1 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3 NDC:68788-9687-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/27/2013
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9688(NDC:66424-021)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code PH013
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9688-1 15 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:68788-9688-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/27/2010
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK(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.