Label: CVS- childrens stuffy nose and cold solution

  • 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 September 14, 2023

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  • Drug Facts

    Active ingredients (in each 5 mL)

    Guaifenesin, USP 100 mg

    Phenylephrine HCl, 2.5 mg

  • Purposes

    Expectorant
    Nasal Decongestant

  • Uses

    ▪
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    ▪
    temporarily relieves:
    ▪
    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 the child has

    ▪
    heart disease
    ▪
    high blood pressure
    ▪
    thyroid disease
    ▪
    diabetes
    ▪
    cough that occurs with too much phlegm (mucus)
    ▪
    persistent or chronic cough such as occurs with asthma
  • When using this product

     
    Do not use more than directed
  • Stop use and ask a 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 (1-800-222-1222).

  • Directions

    ▪
    do not give more than 6 doses in any 24 hour period
    ▪
    measure only with dosing cup provided
    ▪
    do not use dosing cup with other products
    ▪
    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: sodium 3 mg
    ▪
    very low sodium 
    ▪
    store at room temperature
    ▪
    do not refrigerate
    ▪
    dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

  • Questions or Comments?

    1-866-467-2748

  • Package Label-Principal Display Panel 4 FL OZ (118 mL Bottle)

    Compare to the Active Ingredients in Children’s Mucinex® Stuffy Nose & Cold

    NDC 69842-487-04

    Children's Stuffy Nose & Cold Relief

    Guaifenesin

    Expectorant

    Phenylephrine Hcl

    Nasal Decongestant

    •
    Stuffy Nose
    •
    Chest Congestion
    •
    Breaks Up Mucus

    Dosage Cup Included

    For Ages 4 & Over

    Dye Free
    Mixed Berry Flavor

    Naturally and Artificially Flavored

    4 FL OZ (118 mL)

    TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

    IMPORTANT: Keep this carton for future reference on full labeling.

    Distributed by:


    CVS Children's Stuffy Nose and Cold Relief Syrup
  • INGREDIENTS AND APPEARANCE
    CVS 
    childrens stuffy nose and cold solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-487
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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
    ColorPINKScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-487-041 in 1 CARTON03/01/2022
    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 finalpart34103/01/2022
    Labeler - CVS PHARMACY, INC (062312574)
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