Label: CHILDRENS MULTI-SYMPTOM COLD- 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 November 29, 2022

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  • ACTIVE INGREDIENT(S)

    Dextromethorphan HBr 5mg

    Guaifenesin 100 mg

    Phenyephrine HCl 2.5 mg

  • PURPOSE

    Cough Suppressant

    Expectorant

    Phenylephrine HCl

  • USE(S)

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
    • nasal congestion due to a cold
    • stuffy nose
  • WARNINGS

    .

  • DO NOT USE

    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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • persistent or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (mucus)
  • WHEN USING THIS PRODUCT

    do not use more than directed

  • STOP USE AND ASK DOCTOR IF

    • your child gets nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or occur with fever
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

     These could be signs of a serious illness.

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • dose as follows or as directed by a doctor
    • mL = milliliter


    Age Dose  
    children 6 years to under 12 years  10 mL every 4 hours
     children 4 years to under 6 years  5 mL every 4 hours
     children under 4 years do not use



  • OTHER INFORMATION

    • each 5 mL contains: potassium 5 mg, sodium 5 mg
    • store between 15-30°C (59-86°F)
    • do not refrigerate
    • dosing cup provided
  • INACTIVE INGREDIENTS

    anhydrous citric acid, D&C red # 33, dextrose, edetate disodium, FD&C blue # 1, FD&C Red #40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl gallate, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-715-03

    equateTM

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

    Children's

    Multi-Symptom Cold

    Dextromethorphan HBr 5 mg

    Cough Suppressant

    Guaifenesin 100 mg

    Expectorant

    Phenylephrine HCl 2.5 mg

    Nasal Decongestant

    Ages 4 to 12 years

    • Relieves Stuffy Nose   
    • Soothes Cough   
    • Relieves Chest Congestion   
    • Thins and loosens Mucus
    • Alcohol Free

    Very Berry Flavored 
    4 FL OZ (118 mL)
    615-Equate-4

  • INGREDIENTS AND APPEARANCE
    CHILDRENS MULTI-SYMPTOM COLD 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-715
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-715-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/01/2014
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(49035-715)
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