CHILDRENS ALLERGY PLUS CONGESTION RELIEF- diphenhydramine hcl, phenylephrine hcl solution 
Rite Aid Corporation

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.

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Rite Aid Corporation Children’s Allergy Plus Congestion Relief Drug Facts

Active ingredients (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
stuffy nose
itching of the nose or throat
nasal congestion
itchy, watery eyes
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing
nasal congestion
stuffy nose
temporarily relieves sinus congestion and pressure

Warnings

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

do not exceed recommended dose
marked drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

If pregnant or breast-feeding,

ask a health professional before use.

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 hours
do not take more than 6 doses in 24 hours

Age (yr)

Dose (mL)

children under 4 years

do not use

children 4 to 5 years

do not use unless

directed by a doctor

children 6 to 11 years

5 mL

adults and children 12 years and over

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 10 mg
store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients of Children’s Benadryl® Allergy Plus Congestion

6 YEARS & OLDER

CHILDREN’S ALLERGY PLUS CONGESTION RELIEF

alcohol free - oral solution

DIPHENHYDRAMINE HCl 12.5 mg

ANTIHISTAMINE

PHENYLEPHRINE HCl 5 mg

NASAL DECONGESTANT

for relief of:

sneezing, runny, itchy or stuffy nose

itchy, watery eyes

itchy throat – sinus congestion

GRAPE FLAVOR

DOSAGE CUP INCLUDED

4 FL OZ (118 mL)

childrens allergy plus congestion relief image
CHILDRENS ALLERGY PLUS CONGESTION RELIEF 
diphenhydramine hcl, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1119
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorPURPLE (clear) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1119-11 in 1 CARTON06/21/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/21/2018
Labeler - Rite Aid Corporation (014578892)

Revised: 9/2019
Document Id: 409bf783-d6cc-4c5d-a30e-441292293b02
Set id: 197c6a9e-e1b9-473a-a2bd-d9bb6f23b6eb
Version: 2
Effective Time: 20190918
 
Rite Aid Corporation