DIPHENHYDRAMINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

Eon Labs, Inc.

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
DRUG FACTS
ACTIVE INGREDIENT (IN EACH CAPSULE)
Diphenhydramine Hydrochloride 25 mg
Diphenhydramine Hydrochloride 50 mg
PURPOS E
Antihistamine
US ES
Temporarily relieves these symptoms due to hay fever or other upper
respiratory allergies
•
•
•
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
•
•
•
DO NOT USE with any other product containing diphenhydramine,
including products used topically.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
•
•
WHEN USING THIS PRODUCT
•
•
•
•
•
•
IF PREGNANT OR BREASTFEEDING ask a health professional before use.
runny nose and sneezing
itching of the nose or throat
itchy, watery eyes.
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
taking tranquilizers or sedatives
taking other products containing diphenhydramine
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
KEEP OUT OF THE REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
•
•
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 0185-0