Aurodryl childrens allergy solution

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 istaking 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:sodium14 mg
  • store between 20-25C (68-77F). 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

Ingredients and appearance - Product information

Aurodryl childrens allergy solution- Diphenhydramine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-022
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)
D&c red no. 33 ( UNII: 9DBA0SBB0L)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Cherry ( UNII: BUC5I9595W)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Poloxamer 407 ( UNII: TUF2IVW3M2)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium chloride ( UNII: 451W47IQ8X)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color RED (reddish to pink) Flavor CHERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-022)

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
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

4FL 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

8FL OZ (236 mL)