Amerisource Bergen Children's Allergy Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

GOOD NEIGHBOR PHARMACY CHILDRENS ALLERGY- diphenhydramine hydrochloride solution 
Lake Erie Medical DBA Quality Care Products 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.

----------

Amerisource Bergen Children's Allergy Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• sneezing
• itching of the nose or throat
• runny nose
• itchy, watery eyes

Warnings

Do not use

• with any other product containing diphenhydramine, even one used on skin
• to make a child sleepy

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 is

taking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• excitability may occur, especially in children
• sedatives and tranquilizers may increase drowsiness

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 (1 tsp) contains: sodium 15 mg
• store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
• do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Questions or comments?

1-800-719-9260

GOOD NEIGHBOR PHARMACY CHILDRENS ALLERGY 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55700-465(NDC: 24385-379)
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)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED (Bluish-Red)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55700-465-04	1 in 1 CARTON	12/23/2016	10/11/2019
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	08/15/1989	10/11/2019

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	relabel(55700-465)

Revised: 10/2019

Document Id: fb1cad42-709f-4e4f-8a7d-4c5bcde44b4c

34390-5

Set id: b89a41cb-bef9-49c9-ac67-dc9b5faea17e

Version: 2

Effective Time: 20191021

 

Lake Er