Diphenhydramine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Diphenhydramine Hydrochloride

NCS HealthCare of KY, Inc dba Vangard Labs

Diphenhydramine Hydrochloride Capsules 25mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each banded capsule)

Diphenhydramine HCl 25 

Purpose

Antihistamine 

Diphenhydramine Hydrochloride Uses

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

• runny nose

• sneezing

• itchy, watery eyes

• itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

• runny nose 

• sneezing 

Warnings

Do not use

• to make a child sleepy

• with any other product containing diphenhydramine, even one used on skin 

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• glucoma

• trouble urinating due to an enlarged prostate gland 

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers 

When using this product

• marked drowsiness may occur

• 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 

If pregnant or breast-feeding

ask a health professional before use. 

Keep out of reach of children

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

Directions

• take every 4 to 6 hours

• do not take more than 6 doses in 24 hours

adults and children 12 years of age and over   1 to 2 capsules
children 6 to under 12 years of age 1 capsule
children under 6 years of age do not use this product in children under 6 years of age

Diphenhydramine Hydrochloride Other information

• store at room temperature, see USP

• do not use if either capsule band or imprinted safety seal under cap is broken or missing

• protect from moisture

• contains lactose 

Inactive ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch 

Questions or comments?

(800) 616-2471 

Distributed by: MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

M-29

R05/12

Principal Display Panel

Diphenhydramine Hydrochloride 

Diphenhydramine Hydrochloride

Diphenhydramine Hydrochloride CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0615-7656(NDC:0904-5306)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
ANHYDROUS LACTOSE
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
PINK (White) 4 mm CPC;835 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-7656-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-01-02


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Be sure to consult your doctor before taking any medication!
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