Label: COLD AND CONGESTION CHILDRENS NIGHTTIME- diphenhydramine hci, phenylephrine hcl liquid

  • 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 November 11, 2020

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  • Active ingredients (in each 10 mL)

    Diphenhydramine HCI 12.5 mg

    Phenylephrine HCI 5 mg

  • Purposes

    Antihistamine/Cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms occuring with a cold, hay fever, or other upper respiratory allergies
      • nasal congestion
      • cough
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
  • Warnings

    Do not use

    • to sedate a child or to make a child sleepy
    • 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.
    • with any other product containing diphenhydramine, even one used on skin.

    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
    • cough that occurs with too much phlem (mucus)
    • a breathing problem or chronic cough that last or as occurs with smoking, asthma, chronic bronchitis, or emphysena. 

    Ask a doctor or pharmacist before use if you are

    • taking any other oral nasal decongestant or stimulant
    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • 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

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with a fever
    • cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache.

    These could be signs of a serious condition.

    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 (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • do not exceed recommended dosage
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
     age dose
    adults and children 12 years and over20 mL every 4 hours
     children 6 to 11 years 10 mL every 4 hours
     children under 6 yearsdo not use
  • Other information

    • each 10 mL contains: sodium 6mg
    • store at 20-25°C (68-77°F)
    • Do not refrigerate
    • protect from light
  • Inactive ingredients

    acesulfame potassium anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red # 40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    children's

    COLD & CONGESTION

    DIPHENHYDRAMINE HCI 12.5 mg / ANTIHISTAMINE / COUGH SUPPRESSANT

    PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

    Compare-to Children's Dimetapp® Nighttime Cold & Congestion active ingredients††

    • Nighttime
    • Alcohol Free
    • 6 years & older

    FL OZ (mL)

    GRAPE FLAVOR

    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

  • Package Label

    Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 5 mg

    WALGREENS Children's Cold & Congestion Grape Flavor

  • INGREDIENTS AND APPEARANCE
    COLD AND CONGESTION  CHILDRENS NIGHTTIME
    diphenhydramine hci, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    MALTITOL (UNII: D65DG142WK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0058-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/31/2016
    Labeler - Walgreens (008965063)
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