DIPHENHYDRAMINE HYDROCHLORIDE - diphenhydramine hydrochloride capsule 
Eon Labs, Inc.

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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine Hydrochloride 25 mg

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

• runny nose and sneezing
• itching of the nose or throat
• itchy, watery eyes.

Warnings

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland

Do not use with ny other product containing diphenhydramine, including products used topically.

Ask a doctor or pharmacist before use if you are

• taking tranquilizers or sedatives
• taking other products containing diphenhydramine

When using this product

• Do not exceed recommended dosage
• excitability may occur, especially in children
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• use caution when driving a motor vehicle or operating machinery

If pregnant or breastfeeding ask a health professional before use.

Keep out of the 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: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.
• Children 12 years and under: Consult a Doctor

Inactive ingredients

Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate.

Storage and Handling

Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Manufactured for Sandoz Inc.

Princeton, NJ 08540

Manufactured by Epic Pharma, LLC

Laurelton, NY 11413

L1812

Rev. 11/08

Package Label - Principal Display Panel

NDC 0185-0648-30

DiphenhydrAMINE

Hydrochloride

Capsules USP

25 mg

30 Capsules

Manufactured for Sandoz Inc.

Princeton, NJ 08540

Manufactured by Epic Pharma, LLC

Laurelton, NY 11413

Sandoz

 

Package Label - Principal Display Panel

NDC 0185-0649-30

DiphenhydrAMINE

Hydrochloride

Capsules USP

50 mg

30 Capsules

Manufactured for Sandoz Inc.

Princeton, NJ 08540

Manufactured by Epic Pharma, LLC

Laurelton, NY 11413

Sandoz

DIPHENHYDRAMINE HYDROCHLORIDE  diphenhydramine hydrochloride   capsule

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0185-0648 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 SILICON DIOXIDE   STARCH, CORN   D&C RED NO. 28   FD&C BLUE NO. 1   FD&C RED NO. 40   GELATIN   ANHYDROUS LACTOSE   MAGNESIUM STEARATE   SILICON DIOXIDE   SODIUM LAURYL SULFATE

Product Characteristics Color PINK (pink top/clear body) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code E648 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0185-0648-30 30 CAPSULE In 1 BOTTLE None 2 0185-0648-53 50 CAPSULE In 1 BOTTLE None 3 0185-0648-01 100 CAPSULE In 1 BOTTLE None 4 0185-0648-10 1000 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2000

DIPHENHYDRAMINE HYDROCHLORIDE  diphenhydramine hydrochloride   capsule

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0185-0649 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 SILICON DIOXIDE   STARCH, CORN   D&C RED NO. 28   FD&C BLUE NO. 1   FD&C RED NO. 40   GELATIN   ANHYDROUS LACTOSE   MAGNESIUM STEARATE   SILICON DIOXIDE   SODIUM LAURYL SULFATE

Product Characteristics Color PINK (pink top/pink body) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code E649 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0185-0649-30 30 CAPSULE In 1 BOTTLE None 2 0185-0649-53 50 CAPSULE In 1 BOTTLE None 3 0185-0649-01 100 CAPSULE In 1 BOTTLE None 4 0185-0649-10 1000 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2000

Labeler - Eon Labs, Inc. (012656273)

Establishment
Name	Address	ID/FEI	Operations
Epic Pharma, LLC		827915443	MANUFACTURE

Revised: 03/2011Eon Labs, Inc.