Label: MULTI SYMPTOM COLD CF ADULT- dextromethorphan hbr, guaifenesin, phenylephrine liquid

  • NDC Code(s): 55319-382-04
  • Packager: Family Dollar (FAMILY WELLNESS)
  • 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 30, 2023

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  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 200 mg

    Phenylephrine HCL 10 mg

  • Purposes

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occurring with a cold
      • nasal congestion
      • cough due to minor throat and bronchial irritation
  • Warnings

    Do not use

    if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • diabetes 
    • thyroid disease 
    • trouble urinating due to an enlarged prostate gland 
    • cough that occurs with too much phlegm ( mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema 

    Ask a doctor or pharmacist before use if you are

     taking any other oral nasal decongestant or stimulant.

    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 are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device. 
    • keep dosing cup with product
    • mL = milliliter
    • this adult product is not intended for use in children under 12 years of age
    • adult and children 12 years and over: 10 mL every 4 hours
    • children under 12 years: do not use
  • Other information

    • store between 20-25°C (68°-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

  • Questions or comments?

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

  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENTS OF ROBITUSSIN® PEAK COLD MULTI-SYMPTOM COLD CF*

    ADULT

    Multi-Symptom Cold

    DEXTROMETHORPHAN HBr 

    (Cough Suppressant)

    GUAIFENESIN (Expectorant)

    PHENYLEPHRINE HCL

    (Nasal Decongestant)

    Relieves:

    • Nasal Congestion
    • Cough
    • Mucus

    Non-Drowsy

    Alcohol-free

    For Ages 12 and Over

    FL OZ (mL)

    Dosing Cup Included

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Robitussin® Peak Cold Multi-Symptom Cold CF.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC

    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

  • Package Label

    Dextromethorphan HBr 20 mg, Guaifenesin 200 mg, Phenylephrine HCL 10 mg

    FAMILY WELLNESS Adult Multi-Symptom Cold

  • INGREDIENTS AND APPEARANCE
    MULTI SYMPTOM COLD CF  ADULT
    dextromethorphan hbr, guaifenesin, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-382
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MENTHOL (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-382-041 in 1 BOX03/31/201512/31/2025
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/31/201512/31/2025
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
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