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← See all diphenhydramine hydrochloride brands

diphenhydramine hydrochloride by RedPharm Drug, Inc.

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: RedPharm Drug, Inc.
NDC Code: 67296-0876

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.

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

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

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

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.

DOSAGE & ADMINISTRATION

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

PURPOSE

Antihistamine

KEEP OUT OF THE REACH OF CHILDREN.

In case of overdose, get medical help or contact a Poison Control Center right away.

ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

Diphenhydramine Hydrochloride 50 mg

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-0876(NDC:0185-0648)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
ANHYDROUS LACTOSE 
SODIUM LAURYL SULFATE 
FD&C BLUE NO. 1 
D&C RED NO. 28 
FD&C RED NO. 40 
GELATIN 
MAGNESIUM STEARATE 
Product Characteristics
Colorpink (pink top/clear body) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeE648
Contains    
Packaging
#Item CodePackage Description
1NDC:67296-0876-124 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2000
Labeler - RedPharm Drug, Inc. (828374897)
Establishment
NameAddressID/FEIOperations
RedPharm Drug, Inc.828374897repack(67296-0876), relabel(67296-0876)

 
RedPharm Drug, Inc.

← See all diphenhydramine hydrochloride brands

Medically reviewed on May 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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