Label: SANATOS NIGHTTIME- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

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

Drug Label Information

Updated December 12, 2024

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

  • Drug Facts

  • Active Ingredients and Purposes

    Active ingredients (in each softgel)Purposes
    Acetaminophen 325 mg ..............

    Pain reliever/ fever reducer

    Dextromethorphan HBr 15 mg ......Cough suppressant
    Doxylamine succinate 6.25 mg .....Antihistamine

  • Uses

    Temporarily relieves common cold/flu symptoms

    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
    • and fever reducer
  • Warnings

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

    • more than 4 doses in 24 hours, 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
    • glaucoma
    • a cough that is accompanied by excessive phlegm (mucus)
    • a breathing problem, persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase drowsiness effect
    • avoid alcoholic drinks
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • pain or cough gets worse or lasts more than 5 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, occurs with a rash or a persistent headache that lasts.

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

  • Other information

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

    • do not exceed recommended dosage (see Liver warning)
    • do not exceed 4 doses in a 24 hour period or as directed by a doctor
    Age Dose
    adults and children 12 years and older 2 softgels every 6 hours
    children 4 to under 12 yearsconsult a doctor
    children under 4 years do not use
  • Inactive ingredients

    D&C yellow #10, FD&C blue #1, gelatin, glycerin, methylparaben, polyethylene glycol, 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:

    PHARMADEL LLC

    New Castle, DE, 19720

    /PHARMADELUSA

  • PRINCIPAL DISPLAY PANEL

    SNightPDP

  • INGREDIENTS AND APPEARANCE
    SANATOS  NIGHTTIME
    acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-042
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    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
    ColorgreenScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code SN3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-042-081 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)