Label: SANATOS MULTI SYMPTOM DAYTIME- acetaminophen, dextromethorphan hbr liquid

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

Drug Label Information

Updated December 1, 2023

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

View All Sections
  • Drug Facts

  • Active ingredients & Purposes

    Active ingredients

    (in each 30 mL)

    		Purposes
    Acetaminophen 650 mg Pain reliever/ fever reducer
    Dextromethorphan HBr 20 mgCough suppressant

  • Uses

    Temporarily relieves common cold/flu symptoms associted with

    • minor aches & pains
    • headache
    • sore throat
    • fever
    • cough due to minor throat and bronchial irritation
  • Warnings

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

    • adults take more than 6 doses in 24 hours, which is the maxium daily amount
    • child takes more than 4 doses in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

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

    Do not use

    • 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.
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if user

    • has a sodium restricted diet
    • has liver disease
    • hastrouble urinating due to enlarged prostate gland
    • haspersistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • has a cough that occurs with too much phlegm (mucus)
    • is a child with pain of arthritis


    Ask a doctor or pharmacist before use if the user is

    • taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • use only dosing cup provided
    • shake well before use
    • if you are taking other cold/flu products, read complete labeling before dosing
    adults & children 12 years & over30 mL every 4 hours, do not exceed (child) 4 doses and (adult) 6 doses per 24 hours
    children under 12 years of agedo not use

  • Other information

    • sodium content per tablespoon: 10 mg
    • store at room temperature

    TAMPER EVIDENT: Do not use if imprinted band is missing or broken.

  • Inactive ingredients

    citric acid anhydrous, FD&C yellow #6, flavor, glycerin, menthol, propylene glycol, sodium benzoate, sorbitol solution, sodium citrate, sucralose, xanthan gum, water

  • Questions?

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

  • Distributed by:

    Pharmadel LLC

    New Castle, DE 19720

    www.pharmadel.com

    Facebook/PHARMADELUSA

  • Prinicipal Display Panel

    PDP Sanatos MS Day

  • INGREDIENTS AND APPEARANCE
    SANATOS  MULTI SYMPTOM DAYTIME
    acetaminophen, dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-415
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHOL (UNII: L7T10EIP3A)  
    Product Characteristics
    Colororange (Yellow Orange) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-415-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/01/2023
    Labeler - Pharmadel LLC (030129680)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!