Childrens Allergy Plus Congestion: Package Insert and Label Information

CHILDRENS ALLERGY PLUS CONGESTION- diphenhydramine hydrochloride and phenylephrine hydrochloride liquid
Walgreens

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.

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Phenylephrine HCI 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
    • itchy, watery eyes
    • itching of the nose or throat
    • nasal congestion
  • 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 sedate a child or 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, psychiatic, 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 the child has

  • 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 brochitis

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 beverages
  • 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 get better within 7 days or are accompanied by fever

If pregnant or breast-feeding,

ask a health professional before use

Keep out of the reach of children.

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

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
Age Dose
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 every 4 hours
adults and children 12 years and over 10 mL every 4 hours

Other information

  • each 5 mL contains: sodium 8 mg
  • store between 20-25ºC (68-77ºF)
  • do not refrigerate. Protect from light.

Inactive ingredients

carboxymethylcellulose sodium, citric acid, disodium EDTA, FD&C blue#1, FD&C red #40, flavors, glycerin, purified water, sodium benzoate, sorbital, sucralose, trisodium citrate dihydrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-4PM EST

Principal Display Panel

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

children’s

Allergy & Congestion

PE

DIPHENHYDRAMINE HCI 12.5 mg /

ANTIHISTAMINE

PHENYLEPHRINE HCI 5 mg /

NASAL DECONGESTION

SUGAR FREE

4 — 6 HOUR RELIEF

ALCOHOL FREE

  • Relieves sinus congestion, stuffy nose, runny nose, sneezing, itchy throat or nose & itchy, watery eyes

6 YEARS & OLDER

GRAPE FLAVOR

DOSAGE CUP PROVIDED

††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Benadryl® Allergy Plus Congestion.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD. IL 60015

walgreens.com

Product Label

Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 5 mg
(click image for full-size original)

WALGREENS Children’s Allergy & Congestion PE Grape Flavor

CHILDRENS ALLERGY PLUS CONGESTION
diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0409
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
GLYCERIN
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SUCROSE
FD&C RED NO. 40
CARBOXYMETHYLCELLULOSE SODIUM
SORBITOL
FD&C BLUE NO. 1
EDETATE DISODIUM
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0409-04 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-0409-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 04/30/2015 12/30/2022
Labeler — Walgreens (008965063)

Revised: 11/2020 Walgreens

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