CHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]

CHILDRENS DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]
PDF | XML

NDC 63941-378-04
Set ID 5fa8246f-c79e-47c1-882d-61b5ad5f0657
Category HUMAN OTC DRUG LABEL
Packager Best Choice (Valu Merchandisers Company)
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Phenylephrine HCl 2.5 mg

  • Purposes

    Cough suppressant

    Nasal decongestant

  • Uses

    temporarily relieves:

    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritation 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.

    Ask a doctor before use if the child has

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

    When using this product,

    do not use more than directed.

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever
    • cough persists for more than 7 days, comes back or occurs with a 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 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
    Agedose 
    children 6 to under 12 years of age 10 mL every 4 hours 
    children 4 to 5 years 5 mL every 4 hours 
    children under 4 years do not use 

  • Other information

    • each 5 mL contains: sodium 2 mg
    • store between 20-25°C (68-77°F). Do not refrigerate. 
  • Inactive ingredients

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

  • Questions or comments

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

  • Principal Display Panel

    FOR AGES 4 TO 11YEARS

    COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S TRIAMINIC® DAYTIME COLD & COUGH*

    Children's

    Day Time

    Cold & Cough Syrup

    Dextromethorphan HBr

    • Cough Suppressant

    Phenylephrine HCl

    • Nasal Decongestant

    CHERRY FLAVOR

    Alcohol 0.14%

    FL OZ (mL)

    *This product is not manufactured or distributed by Novartis Consumer Healthcare, distributors of Children's Triaminic® DayTime Cold & Cough.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND THE BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    PROUDLY DISTRIBUTED BY:

    VALU MERCHANDISERS, CO.

    5000 KANSAS AVE

    KANSAS CITY, KS 66106

    www.bestchoicebrand.com

  • Package Label

    Dextromethorphan HBr 5 mg, Phenylephrine HCI 2.5 mg

    Best Choice Children's DayTime Cold & Cough Syrup Cherry Liquid

  • INGREDIENTS AND APPEARANCE
    CHILDRENS DAY TIME COLD AND COUGH 
    dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-378
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-378-041 in 1 BOX07/31/201412/31/2021
    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 FINALpart34107/31/201412/31/2021
    Labeler - Best Choice (Valu Merchandisers Company) (868703513)

Related Drugs