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Allergy by Cardinal Health (Leader) 49781

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Cardinal Health (Leader) 49781
NDC Code: 49781-147

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 HCl 25 mg

Purpose

Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
    • sneezing 
    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat

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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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 overtake 1 to 2 capsules 
children 6 to under 12 years of age take 1 capsule
children under 6 years of age do not use

Other information
  • store between 15-30ºC (59° to 86°F) 
  • Protect from light

Inactive ingredients

butylparaben*, D&C red #28,edible black ink, FD&C blue #1, FD&C red #40, FD&C yellow #6*, gelatin, lactose*, lactose monohydrate*, magnesium stearate*, methylparaben*, polysorbate 80*, propylparaben*, purified water*, sodium lauryl sulphate*, starch

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Benadryl® Allergy active ingredient**

Allergy Capsules

Diphenhydramine HCl 25 mg

Antihistamine

For allergy relief

Runny nose

Sneezing

Itchy throat

Itchy, watery eyes

Capsules

Each capsule individually banded for your protection

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING. 

DISTRIBUTED BY: CARDINAL HEALTH

DUBLIN, OHIO 43047

www.myleader.com

1-800-200-6313

Product Label

Leader Allergy Capsules

ALLERGY 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-147
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
D&C RED NO. 28 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
GELATIN 
LACTOSE, UNSPECIFIED FORM 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
WATER 
SODIUM LAURYL SULFATE 
STARCH, CORN 
Product Characteristics
ColorWHITE, PINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeCPC835;DH;25
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-147-241 BOTTLE, PLASTIC in 1 BOX
124 CAPSULE in 1 BOTTLE, PLASTIC
2NDC:49781-147-511 BOTTLE, PLASTIC in 1 BOX
2100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/31/2016
Labeler - Cardinal Health (Leader) 49781 (097537435)

Revised: 02/2016
 
Cardinal Health (Leader) 49781

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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