childrens allergy plus congestion relief

Manufacturer
Rite Aid Corporation
Effective date
2019-09-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:09:41

Label at a glance#

Productchildrens allergy plus congestion relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Indications and 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

Dosage and administration

• 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 dosin...

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

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 image

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-111911822-1119-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ede7b2a3-08ee-4ba5-ac01-8cd18618675b197c6a9e-e1b9-473a-a2bd-d9bb6f23b6eb2024-11-06WarningsExact identifier
spl set id: 197c6a9e-e1b9-473a-a2bd-d9bb6f23b6eb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.