Label: DRX CHOICE CHILDRENS STUFFY NOSE AND CHEST CONGESTION- guaifenesin and phenylephrine hcl solution

  • NDC Code(s): 68163-748-04
  • Packager: RARITAN PHARMACEUTICALS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 29, 2025

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  • Drug Facts

    Active ingredients (in each 5 mL)

    Guaifenesin, USP 100 mg

    Phenylephrine HCl, USP 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 usein 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

    • nervousness, dizziness or sleeplessness occur
    • 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
    • dose as follows or as directed by a doctor

    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 dihydrate, 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 & Chest Congestion

    NDC 68163-748-04

    DRx Choice®

    Children's

    Stuffy Nose & Chest Congestion


    Guaifenesin (Expectorant)
    Phenylephrine HCl (Nasal Decongestant)

    Relieves: Stuffy Nose, Chest congestion, Breaks Up Mucus

    Dosage Cup Included

    Mixed Berry Flavor

    Naturally & artificially flavored

    For Ages 4 & Over

    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.

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court. East Brunswick

    NJ 08816


    DRx Choice Children's Stuffy Nose and chest Congestion
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE CHILDRENS STUFFY NOSE AND CHEST CONGESTION 
    guaifenesin and phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-748
    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)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    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:68163-748-041 in 1 CARTON04/24/2023
    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 DrugM01204/24/2023
    Labeler - RARITAN PHARMACEUTICALS (127602287)
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