ADULT TUSSIN PEAK COLD MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]

ADULT TUSSIN PEAK COLD MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [AUROHEALTH LLC]
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NDC 58602-514-20
Set ID 9b25af98-d826-4a45-80b2-ae447b1fe2ed
Category Human OTC Drug Label
Packager Aurohealth LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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 (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)

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