CHILDRENS ALLERGY PLUS CONGESTION- diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

Childrens Allergy Plus Congestion by

Drug Labeling and Warnings

Childrens Allergy Plus Congestion by is a Otc medication manufactured, distributed, or labeled by Hy-Vee. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, the common cold, or other upper respiratory allergies
  • runny nose
  • sneezing
  • stuffy nose
  • itchy, watery eyes
  • itching of the nose or throat
  • ​nasal congestion
• 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 the child is

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
• shake well before using

• 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

anhydrous citric acid,carboxymethylcellulose sodium, 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 toll free 1-800-289-8343 Monday-Friday 9AM-4PM CST

Principal Display Panel

*Compare to the Active Ingredients of Children's Benadryl® Allergy Plus Congestion

Ages 6 years and older

Children's Allergy + Congestion

Diphenhydramine HCl 12.5 mg - Antihistamine

Phenylephrine HCI 5 mg - Nasal Decongestant

SUGAR FREE ALCOHOL FREE

Allergy & Congestion Relief

Relief of:

• Sinus Congestion
• Stuffy Nose
• Runny Nose
• Itchy, Watery Eyes
• Sneezing
• Itchy Throat or Nose

GRAPE FLAVOR

*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 PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY HY-VEE, INC.

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

www.hy-vee.com

Product Label

Hy-Vee health Children's Allergy + Congestion

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY PLUS CONGESTION 
diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-049
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-049-04	1 in 1 BOX	04/30/2015
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Labeler - Hy-Vee (006925671)