CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE WITH PE (CHILDRENS TYLENOL PLUS MULTI-SYMPTOM COLD) SUSPENSION [P & L DEVELOPMENT, LLC]

CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE WITH PE (CHILDRENS TYLENOL PLUS MULTI-SYMPTOM COLD) SUSPENSION [P & L DEVELOPMENT, LLC]
PDF | XML

NDC 49580-1434-4
Set ID ad788820-1320-4e21-9b9f-82dc0e454335
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active Ingredients

    Acetaminophen 160 mg
    Chlorpheniramine maleate 1 mg
    Dextromethorphan HBr 5 mg
    Phenylephrine HCI 2.5 mg

  • Purposes

    Acetaminophen...........................Pain reliever/fever reducer
    Chlorpheniramine maleate..........Antihistamine
    Dextromethorphan HBr..............Cough suppressant
    Phenylephrine HCI......................Nasal decongestant

  • Uses

    • temporarily relieves the following cold/flu
    symptoms: • minor aches and pains • cough
    • headache • sore throat • sneezing and runny nose
    • stuffy nose • temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen.
    Severe liver damage may occur if your child takes:
    • more than 5 doses in 24 hours, which is the
    maximum daily amount
    • with other drugs containing acetaminophen
    Sore throat warning: If sore throat is severe,
    persists for more than 2 days, is accompanied or
    followed by fever, headache, rash, nausea,
    or vomiting, consult a doctor promptly.

  • Do Not Use

    • to make a child sleepy
    • 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 drug containing acetaminophen
    (prescription or non-prescription). If you are not
    sure whether a drug contains acetaminophen,
    ask a doctor or pharmacist.

  • Ask a doctor before use if the child has

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

  • Ask a doctor or pharmacist before use if the child is taking

    • sedatives or tranquilizers
    • the blood thinning drug warfarin

  • When using this product

    • do not exceed recommended dosage (see overdose warning)
    • may cause excitability, especially in children
    • marked drowsiness may occur • sedatives and
    tranquilizers may increase drowsiness

  • Stop use and ask a doctor if

    • new symptoms occur
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • pain, nasal congestion or cough gets worse or
    lasts for more than 5 days
    • nervousness, dizziness or sleeplessness occur
    • cough comes back or occurs with rash or headache
    that lasts. These could be signs of a serious
    condition

  • Keep this and all drugs out of the reach of children.

    Overdose Warning: Taking more than the
    recommended dose (overdose) could cause serious
    health problems, including liver damage. In case of
    accidental overdose, seek professional assistance or
    contact a Poison Control Center immediately. Quick
    medical attention is critical even if you do not notice
    any signs or symptoms.

  • Directions

    • do not exceed recommended dosage
    (see overdose warning) • shake well before using
    • find right dose on chart below. If possible, use
    weight to dose; otherwise, use age
    • if needed, repeat dose every 4 hours while
    symptoms last
    • do not give more than 5 times in 24 hours

    Weight (lb)                    Age (yr)                    Dose (tsp or mL)
    under 36                         under 4                      do not use
    36-47                                4-5                             do not use unless directed by a doctor
    48-95                                6-11                           2 tsps or 10 mL

  • Other Information

    • dosage cup provided
    • store at controlled room temperature

  • Inactive Ingredients

    blue 1, carboxymethylcellulose sodium, cellulose,
    citric acid, flavors, glycerin, purified water, red 33,
    red 40, sodium benzoate, sorbitol, sucrose,
    xanthan gum

  • Principal Display Panel

    Children's Plus Multi-Symtpom Cold Grape

    Acetaminophen Fever and sore throat

    Chlorpheniramine maleate Runny nose and sneezing

    Dextromethorphan HBr Cough

    Phenylephrine HCI stuffy nose

    For ages 6 to 11

    Oral suspension

    4 fl oz 118mL

    image of label
  • INGREDIENTS AND APPEARANCE
    CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE  WITH PE
    childrens tylenol plus multi-symptom cold suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-1434
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-1434-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200912/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/01/200912/30/2021
    Labeler - P & L Development, LLC (101896231)

Related Drugs