CHILDRENS ALLERGY- diphenhydramine hydrochloride solution

Childrens Allergy by

Drug Labeling and Warnings

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

• 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 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)

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-500
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)
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)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-500-20	1 in 1 CARTON	09/01/2018
1		236 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(58602-500)