Childrens allergy relief solution

Spl unclassified section

Drug Facts

Active ingredient (in each 5 ml)

Diphenhydramine HCl USP 12.5 mg

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

Warnings

Otc - do not use section

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Otc - ask doctor section

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

Otc - when using section

When using this product

  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Otc - keep out of reach of children section

Keep out of reach of children.

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

Directions

  • find right dose on chart below
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • ml = milliliter

Age (yr)

Dose (mL)

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

5mL to 10 mL

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

Other information

  • each 5 mL contains: sodium 11 mg
  • store at room temperature
  • see bottom panel for lot number and expiration date
  • protect from light
  • contains low sodium

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C red 40, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

Questions or comments?

1-866-467-2748

Ingredients and appearance - Product information

Childrens allergy relief solution- Diphenhydramine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70000-0245
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 12.5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Carboxymethylcellulose sodium, unspecified form ( UNII: K679OBS311)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
Potassium citrate ( UNII: EE90ONI6FF)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color RED Flavor CHERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - CARDINAL HEALTH( 097537435)

Principal display panel

LEADER

NDC 70000-0245-1

COMPARE TO CHILDREN'S
BENADRYL ®active ingredient*

Childrens Allergy Relief

Diphenhydramine HCl Antihistamine
12.5 mg/5 mL Oral Solution

Cherry Flavor

For Relief of:

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

4 FL OZ (118 mL)


DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark Childrens Benadryl ®.

IMPORTANT: Keep this carton for future reference on full labeling.

  • ©2017 Cardinal Health, All Rights Reserved, CARDINAL HEALTH, the Cardinal Health LOGO,LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners
  • CARDINAL HEALTH

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

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