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Aurodryl childrens Allergy by Aurohealth LLC

Dosage form: solution
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Aurohealth LLC
NDC Code: 58602-022

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 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

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

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
  • mL = milliliter
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours 
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
5 mL to 10 mL

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

Other information
  • each 5 mL contains: sodium 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, D&C red no 33,  FD & C red no.40, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Questions or comments?

1-855-274-4122

* This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of  Children's Benadryl® Allergy Liquid.

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

AUROHEALTH

NDC 58602-022-24

Compare to the
active ingredient in
Children's Benadryl® Allergy Liquid*
Aurodryl
Children's
ALLERGY
LIQUID MEDICATION

DIPHENHYDRAMINE HYDROCHLORIDE
12.5 mg/5 mL ORAL SOLUTION

ANTIHISTAMINE

Relieves

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy throat

Cherry
FLAVORED LIQUID
 

Alcohol Free

4 FL OZ (118 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL Bottle)

AUROHEALTH

NDC 58602-022-20

Compare to the
active ingredient in
Children's Benadryl® Allergy Liquid*
Aurodryl
Children's
ALLERGY
LIQUID MEDICATION

DIPHENHYDRAMINE HYDROCHLORIDE
12.5 mg/5 mL
ORAL SOLUTION

ANTIHISTAMINE

Relieves

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy throat

Cherry
FLAVORED LIQUID


Alcohol Free

8 FL OZ (236 mL)







AURODRYL CHILDRENS ALLERGY 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-022
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 
CHERRY 
HIGH FRUCTOSE CORN SYRUP 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SUCRALOSE 
Product Characteristics
ColorRED (reddish to pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-022-241 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:58602-022-201 BOTTLE in 1 CARTON
2236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/13/2015
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-022)

 
Aurohealth LLC

← See all Aurodryl childrens Allergy brands

Medically reviewed on May 8, 2018

Further information

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

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