Label: CHILDRENS ALLERGY PLUS CONGESTION RELIEF- diphenhydramine hcl, phenylephrine hcl solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 18, 2019

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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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