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Diphenhydramine Hydrochloride by Cardinal Health

Medically reviewed on December 12, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Cardinal Health
NDC Code: 70000-0207

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.

0835 - Cardinal

Drug Facts

Active Ingredient

(in each banded capsule)

Diphenhydramine Hydrochloride 25mg

Purpose

Antihistamine

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 child sleepy
  • with any other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to enlargement of the 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
  • use caution 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 age1 capsule
children under 6 years of agedo not use this product in children under 6 years of age

Other Information
  • store at room temperature, USP

Inactive Ingredients

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

Questions or Comments

(800) 231-4670

Distributed By Cardinal Health

Dublin, Ohio 43017

www.myleader.com

Essential to Care™ since 1979

+This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. owner of the registered trademark Benadryl®

© 2016 Cardinal Health. All rights Reserved. Cardinal Health, the Cardinal Health Logo, Leadear and the Leader Logo are trademarks or registered trademarks of Cardinal Health. All other marks are property of their respective owners.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0207-1

Allergy Capsules

Diphenhydramine HCL, 25 mg

Antihistamine

For Allergy Relief

Runny Nose, Itchy Throat, Sneezing and Itchy, Watery Eyes

24 Capsules

Compare to Benadryl® active ingredient+

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0207
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)  
STARCH, CORN 
Product Characteristics
Colorpink (Half pink and half clear with white powder inside banded in red around the middle) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeCPC835
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0207-12 BLISTER PACK in 1 CARTON
112 CAPSULE in 1 BLISTER PACK
2NDC:70000-0207-2100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/13/2017
Labeler - Cardinal Health (097537435)
Registrant - Cardinal Health (097537435)

 
Cardinal Health

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Further information

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

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