Label: CHILDRENS MULTI-SYMPTOM COLD AND FEVER LIQUID- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • 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 January 8, 2018

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

  • ACTIVE INGREDIENTS (in each 10 mL)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenyephrine HCl 5 mg

  • PURPOSE

    Pain reliever / fever reducer

    Cough Suppressant

    Expectorant

    Nasal decongestant

  • USE(S)

    temporarily relieves these common cold and flu symptoms:

    • nasal congestion 
    • stuffy nose
    • cough due to minor throat and bronchial irritation
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • WARNINGS

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


    • more than 5 doses in 24 hous, which is the maximum daily amount
    • with other drugs containing 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

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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

    • liver disease
    • thyroid disease
    • diabetes
    • heart disease
    • high blood pressure
    • a breathing problem such as chronic bronchitis
    • persistent or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (mucus)
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF

    • your child is taking the blood thinning drug warfarin
  • WHEN USING THIS PRODUCT

    do not use more than directed

  • STOP USE AND ASK DOCTOR IF

    • nervousness, dizziness or sleeplessness occur
    • pain, nasal congestion or cough gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • 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 right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • DIRECTIONS

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see Overdose warning)
    • shake well before use
    • do not give more than 5 doses in any 24-hour period
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 days unless directed by a doctor
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    • Children 6 to under 12 years of age: 10 mL in dosing cup provided.
    • mL = milliliter
    • Children under 6 years of age: do not use.
  • OTHER INFORMATION

    • each 10 mL contains: sodium 10 mg
    • store between 15-30°C (59-86°F)
    • do not refrigerate
    • dosing cup provided
  • INACTIVE INGREDIENTS

    citric acid anhydrous, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum.


  • QUESTIONS OR COMMENTS

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-772-03

    equate

    Compare to Children's Mucinex®Multi-Symptom Cold & Fever active ingredients*

    Children's Multi-Symptom Cold & Fever Liquid

    Acetaminophen 325 mg
    Pain reliever/Fever Reducer

    Dextromethorphan HBr 10 mg

    Cough Suppressant
    Guaifenesin 200 mg

    Expectorant
    Phenylephrine HCl 5 mg

    Nasal Decongestant

    AGES 6 to 12 YEARS



    • Relieves nasal and chest congestion
    • Soothes Cough 
    • Reduces fever
    • Thins and loosens Mucus
    • Alcohol Free
    • Berry Burst Flavored 

    4 FL OZ (118 mL)
    772

  • INGREDIENTS AND APPEARANCE
    CHILDRENS MULTI-SYMPTOM COLD AND FEVER LIQUID 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-772
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-772-031 in 1 CARTON08/01/2017
    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 FINALpart34108/01/2017
    Labeler - Wal-Mart Stores, Inc. (051957769)