CHILDRENS ALLERGY PLUS CONGESTION RELIEF (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]

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CHILDRENS ALLERGY PLUS CONGESTION RELIEF (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SOLUTION [RITE AID CORPORATION]
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NDC 11822-1119-1
Set ID 197c6a9e-e1b9-473a-a2bd-d9bb6f23b6eb
Category HUMAN OTC DRUG LABEL
Packager Rite Aid Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each 5 mL)

    Diphenhydramine HCl 12.5 mg

    Phenylephrine HCl 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
    •
    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
  • Warnings

  • Do not use

    •
    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

    •
    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

    taking sedatives or tranquilizers

  • When using this product

    •
    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

    •
    nervousness, dizziness, or sleeplessness occur
    •
    symptoms do not improve within 7 days or occur with a fever
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

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

  • Directions

    •
    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

    •
    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

    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?

    1-800-719-9260

  • 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
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY PLUS CONGESTION RELIEF 
    diphenhydramine hcl, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1119
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLE (clear) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1119-11 in 1 CARTON06/21/2018
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/21/2018
    Labeler - Rite Aid Corporation (014578892)
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