Label: CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE WITH PE- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride suspension 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/09

If you are a consumer or patient please visit this version.

  • Active Ingredients

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

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  • Purposes

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

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  • 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

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  • 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.

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  • 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.

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  • 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

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

    • sedatives or tranquilizers
    • the blood thinning drug warfarin

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  • 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

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  • 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

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  • 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.

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  • 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

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  • Other Information

    • dosage cup provided
    • store at controlled room temperature

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  • Inactive Ingredients

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

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  • Principal Display Panel

    DOLLAR GENERAL
    HEALTH SENSE
    CHILDRENS PLUS MULTI SYMPTOM COLD
    COMPARE TO ACTIVE INGREDIENTS IN CHILDREN'S TYLENOL
    PLUS MULTI-SYMPTOM COLD
    SEE NEW DOSING INFORMATION
    4 FL OZ (118 ML)
    GRAPE FLAVOR

    image of label

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE  WITH PE
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-145
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    CARBOXYMETHYLCELLULOSE SODIUM  
    CELLULOSE, MICROCRYSTALLINE  
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    WATER  
    D&C RED NO. 33  
    FD&C RED NO. 40  
    SODIUM BENZOATE  
    SORBITOL  
    SUCROSE  
    XANTHAN GUM  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (Grape Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-145-04 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/29/2009
    Labeler - Dollar General (068331990)
    Registrant - Aaron Industries, Inc. (101896231)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries, Inc. 101896231 manufacture, analysis
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