Childrens Allergy Plus Congestion (Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride) Liquid [Walgreens] -

CHILDRENS ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREENS]
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NDC	0363-0409-04
Set ID	8aac6bfe-6fe5-40ac-9fd2-390cd615546a
Category	HUMAN OTC DRUG LABEL
Packager	Walgreens
Generic Name
Product Class	alpha-1 Adrenergic Agonist
Product Number
Application Number	PART341

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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

WALGREENS Children's Allergy & Congestion PE Grape Flavor

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCROSE (UNII: C151H8M554)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0409-04	1 in 1 BOX	04/30/2015	12/30/2022
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	04/30/2015	12/30/2022

Labeler - Walgreens (008965063)

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Medic

CHILDRENS ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREENS]

Do not use

Ask a doctor before use if the child has

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of the reach of children.

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