CHILDRENS COLD AND COUGH NIGHTTIME (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]

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CHILDRENS COLD AND COUGH NIGHTTIME (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]
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NDC 55319-079-04
Set ID 530c566e-e700-4944-bf51-fa8c97f351b7
Category HUMAN OTC DRUG LABEL
Packager Family Dollar (FAMILY WELLNESS)
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 6.25 mg

    Phenylephrine HCI 2.5 mg

  • Purposes

    Antihistamine/Cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves
      • sneezing
      • runny nose
      • itchy nose or throat
      • itchy, watery eyes due to hay fever
      • nasal and sinus congestion
      • cough due to minor throat and bronchial irritations as may occur with a cold
  • Warnings

    Do not use

    • in a child under 4 years of age
    • in a child who is 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 child's prescription drug contains an MAOI,  ask a doctor or pharmacist before giving this product.
    • with any other product containing diphenhydramine, even one used on skin
    • for the purpose of making your child sleepy

    Ask a doctor before use if the child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts, or as occurs with asthma
    • a breathing problem such as chronic bronchitis

    Ask a doctor or pharmacist before use if the child is

    taking sedatives or tranquilizers. 

    When using this product,

    • do not exceed recommended dosage
    • marked drowsiness may occur
    • excitability may occur, especially in children
    • sedatives and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not improve within 7 days or occur with a fever
    • cough persists for more than 7 days, comes back or occurs with fever, rash or persistent headache.

    These could be signs of a serious condition.

    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 give more than 6 doses in 24 hours unless directed by a doctor.
    • mL = milliliter
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • shake well before using
    AgeDose 
     children 6 to under 12 years10 mL every 4 hours
     children 4 to under 6 yearsdo not use unless directed by a doctor
     children under 4 years do not use 

  • Other Information

    • each 5 mL contains: sodium 3 mg
    • store between 20-25ºC (68-77ºF). do not refrigerate
    • protect from light
  • Inactive ingredients

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

  • Questions or comments?

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

  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENTS OF CHILDREN'S TRIAMINIC® NIGHTTIME COLD & COUGH*

    Children's

    Cold & Cough Nighttime

    Diphenhydramine HCL Antihistamine/Cough Suppressant

    Phenylephrine HCL Nasal Decongestant

    For Ages 6 to 11 Years

    • Cough
    • Runny, Stuffy Nose
    • Itchy Throat

    Alcohol-Free

    FL OZ (mL)

    GRAPE FLAVOR

    Dosing Cup Included

    *This product is not manufactured or distributed by GSK, Consumer Healthcare, distributor of Children's Triaminic® NightTime Cold & Cough.

    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:

    MIDWOOD BRANDS, LLC

    500 VOLVO PARKWAY

    CHESAPEAKE, VA 23320

  • Package Label

    Diphenhydramine HCL 6.25 mg, Phenylephrine HCL 2.5 mg

    FAMILY WELLNESS Children's Nighttime Cold & Cough

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD AND COUGH  NIGHTTIME
    diphenhydramine hcl, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-079
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-079-041 in 1 BOX11/30/2014
    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 FINALpart34111/30/2014
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
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