DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule
Eon Labs, 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 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 any 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

Product of Japan

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

Product of Japan

Sandoz

DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0185-0648
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0185-0648-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000	12/31/2018
2	NDC:0185-0648-53	50 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000	12/31/2018
3	NDC:0185-0648-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000	05/31/2021
4	NDC:0185-0648-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000	06/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/01/2000	06/30/2021

DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0185-0649
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0185-0649-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000	12/31/2018
2	NDC:0185-0649-53	50 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000	12/31/2018
3	NDC:0185-0649-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000	04/30/2021
4	NDC:0185-0649-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000	06/30/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	05/01/2000	06/30/2021

Labeler - Eon Labs, Inc. (012656273)

Revised: 10/2018

Document Id: 419f717e-45ed-4cb5-9d35-a6d43058cd70

Set id: aab7ad3c-858e-4289-b0ad-626d0a73c580

Version: 13

Effective Time: 20181023

Eon Labs, Inc.