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NDC 71205-0259-04 Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL Details

Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL

Good Neighbor Pharmacy Childrens Allergy is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 71205-0259-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	71205-0259
Product ID	71205-259_545f18f8-d14f-498a-ad60-a08059ca7b4f
Associated GPIs	41200030100920
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Good Neighbor Pharmacy Childrens Allergy
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/5mL
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0259-04 (71205025904)

Pricing Information	N/A
NDC Package Code	71205-259-04
Billing NDC	71205025904
Package	1 BOTTLE in 1 CARTON (71205-259-04) / 118 mL in 1 BOTTLE
Marketing Start Date	2019-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9e067482-8735-4476-a82e-438dd24d4289 Details

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

Principal Display Panel

Compare to Children’s Benadryl® Allergy active ingredient

children’s

Allergy

Antihistamine

12.5 mg/5 mL

diphenhydramine HCl

oral solution

For Allergy Relief

Runny Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat

4-6 Hours/Dose

Alcohol Free

Cherry Flavored

4 fl oz (118 mL)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

GOOD NEIGHBOR PHARMACY CHILDRENS ALLERGY

diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-259(NDC:24385-379)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-259-04	1 in 1 CARTON	05/01/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/15/1989

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-259) , RELABEL(71205-259)

Revised: 5/2022

Document Id: 545f18f8-d14f-498a-ad60-a08059ca7b4f

Set id: 9e067482-8735-4476-a82e-438dd24d4289

Version: 3

Effective Time: 20220501