Label: SANATOS DAYTIME- acetaminophen, dextromethorphan, phenylephrine capsule, liquid filled

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

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

  • Active ingredients and Purposes

    Active ingredients (in each softgel)Purposes
    Acetaminophen 325 mg ....................Pain reliever/ fever reducer
    Dextromethorphan HBr 10 mg .........

    Cough suppressant
    Phenylephrine HCl 5 mg ..................

    Nasal decongestant

  • Uses

    Temporarily relieves common cold/flu symptoms

    • headache
    • minor aches and pains
    • nasal congestion due to hay fever or other upper respiratory allergies
    • sinus congestion and pressure
    • and reduces fever
  • Warnings

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

    • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

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

    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 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.
    • for more than 3 days for fever unless directed by a doctor

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • symptoms do not improve within 7 days, tend to recur, or are accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    • new symptoms occur
    • redness or swelling is present
    • nervousness, dizziness, or sleeplessness occur

    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 (see Liver warning)
    • do not exceed 4 doses in a 24 hour period
    Age

    Dose

    adults and children 12 years and older2 softgels every 6 hours
    children 4 to under 12 yearsconsult a doctor
    children under 4 yearsdo not use
  • Other information

    • store between 68-77°F (20-25°C)
    • avoid excessive heat
    • do not use if blister pack unit is punctured or torn
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, methylparaben, polyethylene glycol 400, povidone k-30, propylene glycol, propylparaben, sorbitol, titanium dioxide, water.

  • Questions or comments?

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

  • Distributed by:

    Distributed by:

    PHARMADEL LLC

    New Castle, DE, 19720

    /PHARMADELUSA

  • Principal Display Panel

    SDPDP8

  • INGREDIENTS AND APPEARANCE
    SANATOS  DAYTIME
    acetaminophen, dextromethorphan, phenylephrine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-041
    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 HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code SN2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-041-081 in 1 CARTON04/04/2023
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/04/2023
    Labeler - Pharmadel LLC (030129680)
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