Label: SAFETUSSIN PM NIGHTTIME COUGH RELIEF- dextromethorphan hbr, doxylamine succinate liquid

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

Drug Label Information

Updated December 15, 2023

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  • ACTIVE INGREDIENT

    Active ingredients (in each 5mL)

    Purpose

    Dextromethorphan HBr, USP 7.5 mg

    Cough Suppressant

    Doxylamine Succinate 3.125 mg

    Antihistamine

  • Uses

    ▪
    temporarily relieves cough
    ▪
    runny nose and sneezing
  • Warnings

     
    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
    ▪
    .to make a child sleep.
  • Ask a doctor before use if you have

    ▪
    asthma
    ▪
    emphysema
    ▪
    glaucoma
    ▪
    excessive phlegm (mucus)
    ▪
    breathing problem
    ▪
    chronic bronchitis
    ▪
    persistent or chronic cough
    ▪
    cough associated with smoking
    ▪
    trouble urinating due to enlarged prostate gland
    ▪
    a sodium-restricted diet
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

  • 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 cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    ▪
    do not take more than 4 doses in any 24-hour period

    age

    dose

    adults and children 12 years and over

    20 mL every 6 hours

    children under 12 years

    ask a doctor

    children under 4 years

    do not use

  • Other information:

    ▪
    Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F) Save this package for complete information
  • INACTIVE INGREDIENT

    Inactive ingredients:

    citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose

  • PRINCIPAL DISPLAY PANEL

    SAFE FOR ADULTS WITH

    HIGH BLOOD PRESSURE & DIABETES

    Safetussin® PM 
    NightTime
    Cough Relief
    Dextromethorphan HBr 7.5 mg / Cough Suppressant

    Doxylamine Succinate 3.125 mg / Antihistamine

    Safe for adults with
    High Blood Pressure
    Diabetes

    √ Controls Cough
    √ Relieves Sneezing
    √ Relieves runny nose

    SUGAR & ALCOHOL FREE

    4.0 FL OZ (118mL)


    SEGURO PARA ADULTOS CON PRESION ALTA Y DIABETES

    Safetussin® PM
    Alivia la Tos
    Durante la Noche

    Dextromethorphan HBr 7.5 mg / Antiusivo

    Doxylamine Succinate 3.125 mg / Antihistaminíco

    Seguro para adultos con
    Presión Alta
    Diabetes

    √ Calma la tos,
    √ Alivia estornudos
    √ Alivia goteo de la nariz
     
    SIN AZÚCAR Y SIN ALCOHOL

    4 FL. OZ (118 mL)

    Safetussin® PM
    NIGHT TIME
    COUGH RELIEF
    Cough Suppressant / Antihistamine

    Up To
    8 Hours of cough relief 
    to help you rest

    Safetussin® PM contains:

    √ No decongestants

    √ No acetaminophen

    √ No sugar

    √ No alcohol

    √ No sorbitol

    √ No fructose

    √ No gluten

    √ No dyes

    Pharmacist Recommended Brand

    Always read and follow label directions. Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions.
    Questions? Comments?
    Call 1-800-824-4894 

    © 2023 Kramer Laboratories, Inc.
    Bridgewater, NJ 08807 ● kramerlabs.com
    K0723

    Safetussin PM NightTime Cough Relief 4.0 FL OZ (118 mL)
  • INGREDIENTS AND APPEARANCE
    SAFETUSSIN PM NIGHTTIME  COUGH RELIEF
    dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide7.5 mg  in 5 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE3.125 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MINT (UNII: FV98Z8GITP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-221-331 in 1 CARTON07/28/2023
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/28/2023
    Labeler - Kramer Laboratories (122720675)
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