Leader Childrens Allergy

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Cardinal Health
NDC Code: 37205-565

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.

Cardinal Health Allergy Liquid Drug Facts

Active ingredient (in each 5 mL)*

Diphenhydramine HCl 12.5 mg

*5 mL = 1 teaspoon (tsp)

Purpose

Antihistamine

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

Warnings

Do not use
with any other product containing diphenhydramine, even one used on skin
to make a child sleepy

Ask a doctor before use if the child has
a breathing problem such as chronic bronchitis
glaucoma
a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product
marked drowsiness may occur
excitability may occur, especially in children
sedatives and tranquilizers may increase drowsiness

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
find right dose on chart below
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
take every 4 to 6 hours
do not take more than 6 doses in 24 hours

Age (yr)

Dose

children under 2 years

do not use

children 2 to 5 years

do not use unless directed by a doctor

children 6 to 11 years

5 to 10 mL (1 to 2 tsp)

Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device

Other information
each teaspoon contains: sodium 15 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Questions or comments?

1-800-719-9260

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SEE NEW WARNINGS & DIRECTIONS

Compare to Children’s Benadryl® Allergy active ingredient

Ages 6 to 11

CHILDREN'S

Allergy Liquid

Diphenhydramine HCl Oral Solution

Antihistamine

For Allergy Relief

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

Cherry Flavor

Alcohol Free

Allergy Liquid Carton Image 1

Allergy Liquid Carton Image 2

LEADER CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-565
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C RED NO. 40 
HIGH FRUCTOSE CORN SYRUP 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SORBITOL 
GLYCERIN 
Product Characteristics
ColorRED (Bluish-Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-565-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:37205-565-341 BOTTLE in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/15/1990
Labeler - Cardinal Health (097537435)

Revised: 08/2012
 
Cardinal Health

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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