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Diphenhydramine by Central Texas Community Health Centers

Medically reviewed on Aug 28, 2017

Dosage form: solution
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Central Texas Community Health Centers
NDC Code: 76413-333

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.

McKesson Allergy Relief 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 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 - 118 ml Bottle Label

Austin/Travis Co. Health & Human Services Dept.

Diphenhydramine
Soln.118ml

Date:

Name:
Dr.

USE AS DIRECTED

1/1/01

123456

Diphenhydramine Sol.12.5mg/5ml #118ml 76413-333-01

Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

DIPHENHYDRAMINE 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-333(NDC:49348-045)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE, UNSPECIFIED FORM 
SORBITOL 
Product Characteristics
ColorRED (Bluish-Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:76413-333-01118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/21/2003
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIOperations
Central Texas Community Health Centers079674019REPACK(76413-333), RELABEL(76413-333)

 
Central Texas Community Health Centers

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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