CHILDRENS ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HY-VEE]

CHILDRENS ALLERGY PLUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HY-VEE]
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NDC 42507-049-04
Set ID 3893f772-6168-4e51-9eb5-e73989547a9a
Category HUMAN OTC DRUG LABEL
Packager Hy-Vee
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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

    Diphenhydramine HCI 12.5 mg Phenylephrine HCI 5 mg

    Hy-Vee health Children's Allergy + Congestion

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY PLUS CONGESTION 
    diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-049
    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)  
    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    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42507-049-041 in 1 BOX04/30/201512/31/2021
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/30/201512/31/2021
    Labeler - Hy-Vee (006925671)

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