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

Drug Label Information

Updated July 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)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    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 DrugM01208/01/2020
    Labeler - Pharmadel LLC (030129680)