DAYTIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC]

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DAYTIME COLD AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0378-4
Set ID 7d8ccd41-115f-4db7-a978-6775411c5f95
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • 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 the 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
    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts, or as occurs with asthma

    When using this product,

    do not exceed recommended dosage.

    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 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
     Age Dose
     children 6 to under 12 years of age 10 mL every 4 hours
     children 4 to under 6 years of age 5 mL every 4 hours
     children under 4 years of age 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

    Compare to the active ingredients in Children's Triaminic® DayTime Cold & Cough*

    Children's triacting daytime Cold & Cough

    dextromethorphan HBr 5 mg Cough suppressant

    phenylephrine HCl 2.5 mg Nasal decongestant

    relieves:

    • cough
    • stuffy nose

    for ages 4 to 11

    alcohol 0.14 %

    Cherry Flavor

    FL OZ (mL)

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

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

    Manufactured by:

    PL Developments

    11865 S. Alameda St

    Lynwood, CA 90262

  • Package Label

    Dextromethorphan HBr 5 mg, Phenylephrine HCL 2.5 mg

    READYinCASE Children Triacting Day Time Cold & Cough Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND COUGH  CHILDRENS
    dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0378
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 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)  
    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:49580-0378-4118 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 - P & L Development, LLC (101896231)
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