Label: ADULT TUSSIN PEAK COLD 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 28, 2019

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

  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP 20 mg
    Guaifenesin, USP 200 mg
    Phenylephrine HCl, USP 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
    • thyroid disease
    • diabetes
    • 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
    • you get nervous, dizzy, or sleepless
    • 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 right away (1-800-222-1222).

  • Directions


    • do not take more than 6 doses (12 tsp) in any 24-hour period
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • this adult product is not intended for use in children under 12 years of age

    Age
    Dose
    adults and children
    12 years and over
    10 mL
    every 4 hours
    children under 12 years
    do not use

  • Other information

    • each 10 mL contains: sodium 6 mg
    • store at 20-25°C (68-77°F). Do not refrigerate
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, FD&C Red No. 40 powder, glycerin, menthol, noncrystallizing sorbital solution, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose.

  • Questions or Comments

    1-855-274-4122

    Distributed by:
    Aurohealth LLC.
    2572 Brunswick Pike,
    Lawrenceville, NJ 08648

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Label)

    NDC 58602-514-20
    Primary Health

    Compare to Adult Robitussin®
    Peak Cold Multi-Symptom Cold
    Active ingredients*

    ADULT
    Tussin
    PEAK COLD
    Multi-Symptom Cold

    Each 10 mL dose of oral solution contains:
    20 mg - Dextromethorphan HBr, USP (Cough Suppressant)
    200 mg - Guaifenesin, USP (Expectorant)
    10 mg- Phenylephrine HCl, USP (Nasal Decongestant)

    Relieves:

    • Cough
    • Nasal Congestion
    • Mucus 
    • For Ages 12 & Over

    Raspberry Flavor
    Non-Drowsy                                       
    8 FL OZ(237 mL)


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Label)



  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Carton Label)

    NDC 58602-514-20
    Primary Health

    Compare to Adult Robitussin®
    Peak Cold Multi-Symptom Cold
    Active ingredients*

    ADULT
    Tussin
    PEAK COLD
    Multi-Symptom Cold

    Each 10 mL dose of oral solution contains:
    20 mg - Dextromethorphan HBr, USP (Cough Suppressant)
    200 mg - Guaifenesin, USP (Expectorant)
    10 mg- Phenylephrine HCl, USP (Nasal Decongestant)

    Relieves:

    • Cough
    • Nasal Congestion
    • Mucus
    • For Ages 12 & Over

    Rasberry Flavor
    Non-Drowsy                                       
    8 FL OZ(237 mL)


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -8 FL OZ (237 mL Container Carton Label)


  • INGREDIENTS AND APPEARANCE
    ADULT TUSSIN PEAK COLD MULTI-SYMPTOM COLD 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-514
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED (a clear red co lo red liquid) Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-514-201 in 1 CARTON09/25/2018
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/25/2018
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-514)