Label: CHILDRENS PLUS COUGH AND RUNNY NOSE- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspension

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 February 5, 2018

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

  • Active ingredients (in each 5 mL)

    Acetaminophen 160 mg

    Chlorpheniramine maleate 1 mg

    Dextromethorphan HBr 5 mg

    Close
  • Purposes

    Pain reliever/fever reducer

    Antihistamine

    Cough suppressant

    Close
  • Uses

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

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

    • more than 5 doses (10 mL) in 24 hours, which is the maximum daily amount
    • with other drugs contaning acetaminophen

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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.
    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use if the child has

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

    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 dose (see overdose warning )
    • excitability may occur, 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 or cough gets worse or lasts for more than 5 days
    • cough comes back or occurs with rash or headache that lasts 

    These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

    Close
  • Directions

    • this product does not contain directions or complete warnings for adult use.
    • mL = milliliter
    • shake well before using
    • do not give more than 5 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • if needed, repeat dose every 4 hours while symptoms last
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age
    Weight (lb) Age (yr) Dose (mL)
     48-95  6-11  10 mL
     36-47  4-5  do not use unless directed by a doctor
     under 36  under 4 do not use
    Close
  • Other Information

    • store between 20-25ºC (68-77ºF). Do not refrigerate.
    Close
  • Inactive ingredients

    acesulfame potassium, alcohol, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose purified water, sodium benzoate, sorbitol, xanthan gum

    Close
  • Questions or comments?

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

    Close
  • Principal Display Panel

    *Compare To Active Ingredients in Children's Tylenol® Plus Cough & Runny Nose

    Children's Plus COUGH & RUNNY NOSE

    Pain Reliever, Fever Reducer,

    Cough Suppressant, Antihistamine

    RELIEVES:

    • Fever & Sore Throat

    Acetaminophen

    • Sneezing & Runny Nose

    Chlorpheniramine Maleate

    • Cough

    Dextromethorphan HBr

    Alcohol 0.005%

    Oral Suspension

    FOR AGES 6 TO 11 YEARS

    FL OZ (mL)

    CHERRY

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Cough & Runny Nose.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: fred's, Inc.

    4300 NEW GETWELL RD, MEMPHIS,TN 38118

    www.fredsinc.com

    Questions or comments: 1855-331-FRED (3733)

    Close
  • Package Label

    Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg

    FRED'S Children's Plus Cough & Runny Nose Cherry Flavor

    Close
  • INGREDIENTS AND APPEARANCE
    CHILDRENS PLUS COUGH AND RUNNY NOSE 
    acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-297
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-297-04 1 in 1 BOX 12/17/2015
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/17/2015
    Labeler - Freds Inc (005866116)
    Close