GOOD NEIGHBOR PHARMACY CHILDRENS ALLERGY- diphenhydramine hydrochloride solution

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Proficient Rx LP
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine
Authorization status:
OTC monograph final
Authorization number:
71205-259-04

GOOD NEIGHBOR PHARMACY CHILDRENS ALLERGY- diphenhydramine

hydrochloride solution

Proficient Rx LP

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

Purpos e

Antihistamine

Us es

Warnings

Do not use

Ask a doctor before use if the child has

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product

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).

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

with any other product containing diphenhydramine, even one used on skin

to make a child sleepy

a breathing problem such as chronic bronchitis

glaucoma

a sodium-restricted diet

marked drowsiness may occur

excitability may occur, especially in children

sedatives and tranquilizers may increase drowsiness

Directions

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

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

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

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

4-6 Hours/Dose

Alcohol Free

Cherry Flavored

4 fl oz (118 mL)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

GOOD NEIGHBOR PHARMACY CHILDRENS ALLERGY

diphenhydramine hydrochloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7120 5-259 (NDC:2438 5-379 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE

- UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

12.5 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Proficient Rx LP

GLYCERIN (UNII: PDC6 A3C0 OX)

HIGH FRUCTO SE CO RN SYRUP (UNII: XY6 UN3QB6 S)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics

Color

RED (Bluish-Red)

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7120 5-259 -0 4

1 in 1 CARTON

0 5/0 1/20 19

1

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 8 /15/19 8 9

Labeler -

Proficient Rx LP (079196022)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pro ficient Rx LP

0 79 19 6 0 22

REPACK(7120 5-259 ) , RELABEL(7120 5-259 )

Revised: 10/2019

Similar products

Search alerts related to this product

View documents history

Share this information