DIPHENHYDRAMINE HYDROCHLORIDE - diphenhydramine hydrochloride capsule 
BANOPHEN - diphenhydramine hydrochloride capsule 
Major Pharmaceuticals

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Diphenhydramine Hydrochloride Capsules

Active ingredient

Diphenhydramine Hydrochloride 25 mg

Purpose

Antihistamine

Use

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.

Warning

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.

Pregnancy/breast-feeding warning

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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 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

Lactose, starch, gelatin with bisulfites and artificial colors.

Questions?

Adverse drug event call: (800) 616-2471

Principal display panel

Diphenhydramine Hcl 25 mg Caps

Diphenhydramine Hcl 25 mg Caps

Active ingredient

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Use

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.

Warning

Ask a doctor before use if you have glucoma, 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 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.

Pregnancy/breast-feeding warning

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

Directions

Adults and children 12 years and over: take 50 mg (1 capsule) 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 childrent under 12 years of age is available on the 25 mg package.

Other information

Store at controlled room temperature (59-86 degrees F). Protect from excessive moisture.

Inactive ingredients

Lactose, starch, gelatin with bisulfites and artificial colors

Questions?

Adverse drug event call: (800) 616-2471

Principal display panel

Diphenhydramine Hcl 50 mg Caps

Diphenhydramine Hcl 50 mg Caps

Banophen 50 mg caps

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride   capsule
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0904-5306
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE  
STARCH, CORN  
GELATIN  
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
MAGNESIUM STEARATE  
D&C RED NO. 28  
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 4mm
Flavor Imprint Code cpc;835
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0904-5306-60 100 CAPSULE In 1 BOTTLE None
2 0904-5306-61 100 CAPSULE In 1 BOX, UNIT-DOSE None
3 0904-5306-80 1000 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part348 01/02/2009

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride   capsule
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0904-2056
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE  
STARCH, CORN  
GELATIN  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
D&C RED NO. 28  
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 4mm
Flavor Imprint Code cpc;836
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0904-2056-61 100 CAPSULE In 1 BOX, UNIT-DOSE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part348 01/02/2009

BANOPHEN 
diphenhydramine hydrochloride   capsule
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0904-5307
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
LACTOSE  
CROSCARMELLOSE SODIUM  
SILICON DIOXIDE  
FD&C RED NO. 40  
MAGNESIUM STEARATE  
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 4mm
Flavor Imprint Code cpc;836
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0904-5307-60 100 CAPSULE In 1 BOTTLE None
2 0904-5307-80 1000 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part348 01/02/2009

Labeler - Major Pharmaceuticals (191427277)
Revised: 12/2009 Major Pharmaceuticals