Label: SANATOS X- acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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

  • Drug Facts

  • Active ingredients and Purposes

    Active ingredients (in each 20 mL)Purposes
    Acetaminophen 650mg ......Pain reliever/fever reducer
    Dextromethorphan HBr 20 mg .............Cough suppressant
    Guaifenesin 400 mg .....................................Expectorant
    Phenylephrine HCI 10 mg...................Nasal decongestant

  • Uses

    • temporarily relieves these common cold/ flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial
    • secretions to drain bronchial tubes
    • make coughs more productive
    • nasal congestion
    • stuffy nose
    • hay fever
    • temporarily reduces fever
  • Warnings

    Liver warning:

    This product contains acetaminophen.
    Severe liver damage may occur if you:

    • take more than 6 doses in 24 hours, which is the maximum daily amount
    • take with other drugs containing acetaminophen
    • have 3 or more alcoholic drinks every day while using this product

    Allergy alert:

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash If an allergic reaction occurs, stop use and seek medical help right away.

    Sore throat warning:

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you or your child 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 child’s or your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    Ask a doctor before use if you have

    • liver disease
    • high blood pressure
    • a cough that is accompanied with excessive phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, bronchitis, or emphysema
    • diffculty in urination due to enlargement of the prostate gland
    • heart disease
    • thyroid disease
    • diabetes

    Stop use and ask a doctor if

    • skin rash appears
    • symptoms persist for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • nervousness, dizziness, or sleeplessness occur

    These could be signs of a serious condition.

    If pregnant or breastfeeding,

    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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed
    • dosing cup included
    • do not take more than 6 doses in any 24-hour period
    • this product is not intended for use in children under 12 years of age

    agedose
    adults & children 12 years of age & over20 mL every 4 hours
    children under 12 years of agedo not use

  • Other information

    • each 20 mL contains: sodium 10 mg
    • store at 59-86°F (15-30°C)
    • do not refrigerate

    TAMPER EVIDENT FEATURE: Do not use if printed seal under cap is torn or missing.

  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • Questions or comments?

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

  • Principal Display Panel

    MAXIMUM STRENGTH • MÁXIMA POTENCIA

    SANATOS® X

    FAST ACTION/ACCIÓN RÁPIDA

    ACETAMINOPHEN Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI/ACETAMINOFÉN Dextrometorfano HBr,
    Guaifenesina, Fenilefrina HCl

    COUGH, COLD & SORE THROAT/TOS, RESFRIADO y DOLOR DE GARGANTA

    Fever/Fiebre
    Aches and pains/Dolores y molestias leves
    Headache/Dolor de Cabeza
    Expectorant/Expectorante
    Nasal decongestant/Descongestivo Nasal

    For ages 12+/Para edades 12+

    6 fl oz (177 mL)

    Santos X

  • INGREDIENTS AND APPEARANCE
    SANATOS X 
    acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-311
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-311-061 in 1 BOX12/03/2018
    11 in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/03/2018
    Labeler - Pharmadel LLC (030129680)