DYE-FREE CHILDRENS ALLERGY- diphenhydramine hydrochloride solution

Dye-Free Childrens ALLERGY by

Drug Labeling and Warnings

Dye-Free Childrens ALLERGY by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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)

INGREDIENTS AND APPEARANCE

DYE-FREE CHILDRENS ALLERGY 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE (Colorless)	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-501-24	1 in 1 CARTON	09/01/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/01/2018

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-501)