Dye-Free Childrens Allergy

Dye-Free Childrens Allergy

Drug Labeling and Warnings

Drug Details

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DYE-FREE 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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Dye-Free Childrens 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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you

are taking sedatives or tranquilizers

When using this product

  • sedatives and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • 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

  • 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 6 years of age
ask a doctor
children 6 years to under 12 years of age
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 9 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, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution


Questions or Comments?

1-855-274-4122


* This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Dye Free Allergy.

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

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

NDC: 58602-501-24
PrimaryHealth


COMPARE TO children’s
Benadryl® active
ingredient*

Dye-Free Children's
ALLERGY
LIQUID MEDICATION

ANTIHISTAMINE


Diphenhydramine Hydrochloride
12.5 mg/5 mL
Oral Solution


Relieves:

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

Sugar &
Alcohol Free



Dye-Free
Bubble Gum Flavored

4 FL OZ (118 mL)

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

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

NDC: 58602-501-24
PrimaryHealth


COMPARE TO children’s
Benadryl® active
ingredient*

Dye-Free Children's
ALLERGY
LIQUID MEDICATION

ANTIHISTAMINE


Diphenhydramine Hydrochloride
12.5 mg/5 mL
Oral Solution


Relieves:

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

Sugar &
Alcohol Free



Dye-Free
Bubble Gum Flavored

4 FL OZ (118 mL)




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

DYE-FREE CHILDRENS ALLERGY 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-501
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)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (Colorless) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-501-241 in 1 CARTON09/01/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-501)

Revised: 9/2018
 
Aurohealth LLC


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