CHILDRENS ALLERGY - diphenhydramine hydrochloride solution 
Aurohealth LLC

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.

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Children's ALLERGY

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 emphysema or 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 - 8 FL OZ Container Label (236 mL Bottle)

NDC 58602-500-20
PrimaryHealth

COMPARE TO 
Children’s
Benadryl® Allergy Liquid
active ingredient*

Children's
ALLERGY
LIQUID MEDICATION

ANTIHISTAMINE


Diphenhydramine Hydrochloride
12.5 mg/5 mL
Oral Solution

 

Relieves:

  • Runny nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat

Alcohol Free


Cherry Flavored Liquid

8 FL OZ (236 mL)


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


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

NDC 58602-500-20
PrimaryHealth

COMPARE TO 
Children’s
Benadryl® Allergy Liquid
active ingredient*

Children's
ALLERGY
LIQUID MEDICATION

ANTIHISTAMINE


Diphenhydramine Hydrochloride
12.5 mg/5 mL
Oral Solution

 

Relieves:

  • Runny nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat

Alcohol Free


Cherry Flavored Liquid

8 FL OZ (236 mL)

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


CHILDRENS ALLERGY 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-500
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorRED (Reddish to Pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-500-201 in 1 CARTON09/01/201805/01/2022
1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/201805/01/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-500)

Revised: 11/2020
 
Aurohealth LLC