Label: SANATOS TURBO MAX STRENGTH- 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 January 12, 2022

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  • Drug Facts

  • Active ingredients & Purposes

    Active ingredient (in each 20 mL)Purpose
    Dextromethorphan HBr 20 mg...................

    Cough suppressant
    Guaifenesin 400 mg...................................

    Expectorant

    Phenylephrine HCl 10 mg ………….......…Nasal decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily relieves common cold/flu symptoms:
    • cough due to minor throat and bronchial irritationnasal congestion due to hay fever
    • other upper respiratory allergies
    • sinus congestion and pressure
    • stuffy nose
  • Warnings

    Do not use

    • for children under 12 years of age
    • 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 two 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
    • thyroid disease
    • diabetes
    • high blood pressure
    • a cough that occurs with too much phlegm (mucus)
    • a persistent or chronic cough such occurs with smoking, asthma or emphysema
    • trouble urinating due to an enlarged prostate gland

    When using this product

    • do not use more than directed

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • a persistent cough or symptoms do not get better within 7 days
    • cough comes back, or occurs with a 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.

  • Directions

    • do not exceed recommended dosage
    • use dosage cup
    • mL = milliliter
    • do not take more than 6 doses in any 24-hour period
    AgeDose
    adults & children 12 years and older20 mL every 4 hours
    children under 12 years of agedo not use

  • Other information

  • Inactive ingredients

    anhydrous citric acid, dextrose, D&C red # 33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, saccharin sodium, sodium benzoate, sucralose, xanthan gum, water

  • Questions or comments?

    +1-866-359-3478 (M-F) 9 AM to 5 PM Eastern or www.pharmadel.com

    * This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAXTM Severe Congestion & Cough

  • PACKAGE PRINCIPAL DISPLAY PANEL

    PDP Turbo Max

  • INGREDIENTS AND APPEARANCE
    SANATOS TURBO  MAX STRENGTH
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-322
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-322-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/03/2020
    Labeler - Pharmadel LLC (030129680)
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