Label: SANATOS MULTI SYMPTOM- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci tablet

  • NDC Code(s): 55758-361-02, 55758-361-99
  • Packager: Pharmadel LLC
  • 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 May 20, 2022

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  • Drug Facts

  • Active Ingredient & Purposes

    Active ingredients (in each tablet)Purposes
    Acetaminophen 325 mgPain reliever/ fever reducer
    Dextromethorphan HBr 15 mgCough suppressant
    Guaifenesin 200 mg

    Expectorant
    Phenylephrine HCI 5 mgNasal decongestant

  • Uses

    Temporarily relieves common cold/flu symptoms:

    • minor aches & pains
    • headache
    • sore throat
    • nasal congestion due to hay fever
    • sinus congestion
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily reduces fever
  • Warnings

    Liver Warning:

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

    • more than 8 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert:

    Acetaminophen may cause severe skine reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away

    Sore throat warning:

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitting, consult a doctor promptly.

    Do not use

    • with any drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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, asl a doctor or pharmacist before taking this product.
    • for more than 7 days for pain and 3 days or fever, unless directed by a doctor.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • throid disease
    • diabetes
    • trouble urinating due to enlarged prostate gland
    • a cough that is accompained by excessive phlegm (mucus)
    • a persistant or chronic cough such as occurs with smoking, asthma or emphysema

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    If pregnant or breast-feeding,

    ask a health professional before use.

    KEEP OUT OF REACH OF CHILDREN.

    In case of accidental 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 exceed recommended dosage
    • adults and children 12 years of age and over:
    • take 2 tablets every 6-8 hours; do not exceed 8 tablets in a 24-hour period
    • children under 12 years of age: consult a doctor
  • Other information

    • store at room temperature 59-86F (15-30C)
    • avoid excessive heat and humidity

    TAMPER EVIDENCE: Do not use if packet is open or torn.

  • Inactive ingredients

    corn starch, microcrystalline cellulose, povidone-iodine, povidone k30, silicone dioxide, stearic acid, talc

  • Questions & comments?


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

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  • INGREDIENTS AND APPEARANCE
    SANATOS MULTI SYMPTOM 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-361
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE-IODINE (UNII: 85H0HZU99M)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeOVALSize17mm
    FlavorImprint Code A12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-361-022 in 1 PACKET; Type 0: Not a Combination Product08/01/2020
    2NDC:55758-361-9950 in 1 CARTON08/01/2020
    2NDC:55758-361-022 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2020
    Labeler - Pharmadel LLC (030129680)
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