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

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 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 1 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	part345	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 1 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	part345	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 1 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	part345	01/02/2009

Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2009Major Pharmaceuticals