Label: SANATOS NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

  • 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 September 9, 2010

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

  • ACTIVE INGREDIENT


    Active Ingredients                               Purpose

    (in each 15 mL tablespoon)

    Acetaminophen 500mg........         Pain Reliever/Fever Reducer

    Dextromethorphan HBr 15mg......    Cough Suppressant

    Doxylamine succinate 6.25mg..................Antihistamine

  • PURPOSE

    Uses: temporarily relieves common cold/flu symptoms:

    • Cough due to Minor Throat and Bronchial Irritation
    • Sore Throat
    • Headache
    • Minor Aches and Pains
    • Fever
    • runny nose and sneezing


  • WARNINGS

    Warnings: Do not exceed recommended dosage.

    Do not give to children under 12 years of age.


    Liver Toxicity may occur if:

    • Recommended dosage is exceeded
    • Used with other products containing acetaminophen
    • Used with moderate amounts of alcohol
    Alcohol Warning: If you consume 3 or more alcoholic drinks, ask your doctor whether you should take acetaminophen or other pain relievers. Acetaminophen may cause liver damage.
    Sore Throat Warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.


  • DO NOT USE

    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 two 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


  • ASK DOCTOR

    Stop Use and ask a doctor if you have:

    • Glaucoma
    • Trouble urinating due to enlarged prostate gland
    • Cough that occurs with too much phlegm(mucus)
    • Persistent or chronic cough as occurs with smoking, asthma or emphysema
    • Ask a doctor before use if you are taking sedatives or tranquilizers
    Ask a doctor before use if you are taking sedatives or tranquilizers.


  • WHEN USING

    When using this product, do not use more than directed

    • Excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness
  • STOP USE


    Stop Use and ask a doctor if:

    • Pain or cough gets worse or lasts more than 7 days
    • 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. This could be signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING

    If pregnant of breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    Overdose warning: Taking more than the recommended dose can cause serious health problems. 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.

  • DOSAGE & ADMINISTRATION

    Directions: Take only as recommended. See Overdose Warning.

    • use dose cup or tablespoon(TBSP). Do not use more than 4 doses in 24 hours

    Adults and children 12 years and older: Take 2 TBSP(30ml) every 6 hours, while symptoms persist or as directed by a doctor

    Children under 12 years of age: Consult a doctor. Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose(overdose) of acetaminophen and cause serious problems.

  • INDICATIONS & USAGE

    Other information:

    • Store at controlled room temperature 15-30 C (59-86F)
    • each tablespoon contains: potassium 5 mg, sodium 18 mg. Contains 10% alcohol.
  • INACTIVE INGREDIENT


  • QUESTIONS

    Questions? (302) 725-0692

  • PRINCIPAL DISPLAY PANEL

    SanaTosNightLabel

  • INGREDIENTS AND APPEARANCE
    SANATOS  NIGHT
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14505-399
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALCOHOL (UNII: 3K9958V90M)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorANISE (ANISE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14505-399-06177 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/04/2010
    Labeler - Pharmalab Enterprises Inc (174401088)
    Registrant - Pharmalab Enterprises Inc (174401088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmalab Enterprises Inc174401088manufacture