SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID [KRAMER LABORATORIES]

SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID [KRAMER LABORATORIES]
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NDC 55505-173-33
Set ID 0f7e2c22-0c59-4027-ad61-6bdd048a605c
Category HUMAN OTC DRUG LABEL
Packager Kramer Laboratories
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each 5ml tsp)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
    4 teaspoons
    every 6 hours
    children 4 to 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)
    • Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg

    Save this package for complete information

  • INACTIVE INGREDIENT

    Inactive ingredients: aspartame, benzoic acid, citric acid, glycerin, menthol, methylparaben, natural peppermint flavor, propylene glycol, propylparaben, purified water

  • PRINCIPAL DISPLAY PANEL

    Safetussin® PM 
    NIGHT TIME
    COUGH RELIEF
    Cough Suppressant / Antihistamine

    Specially formulated for adults with

    High Blood Pressure
    Diabetes

    Controls Cough
    Relieves Sneezing
    & Runny Nose

    No Sugar
    No Dyes 
    No Gluten
    No Alcohol

    4.0 FL OZ (118mL)

    Safetussin® PM
    ALIVIA LA TOS
    DURANTE LA NOCHE
    Antiusivo / Antihistaminíco

    SEGURO para los que padecen de

    Presión alta
    Diabetes

    Calma la tos,
    alivia estornudos
    y goteo de la nariz
     
    Sin Azúcar
    Sin Colorantes
    Sin Gluten
    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

    Pharmacist Recommended

    Developed by a pharmacist who recognized the need for simple, safe cough relief for adults afflicted with high blood pressure, diabetes or the common cold.

    Specially-formulated Safetussin® is free of alcohol, sugar, dyes, decongestants and other ingredients that are unnecessary for safe, adult-strength cough treatment. Pure and simple.

    Questions? Comments?
    Call 1-800-824-4894 ● safetussin.com


    © 2019 Kramer Laboratories, Inc.
    Bridgewater, NJ 08807 ● kramerlabs.com

    k0519

    carton

    Safetussin® PM
    NIGHT TIME
    COUGH RELIEF
    Cough Suppressant / Antihistamine

    Specially formulated for adults with

    High Blood Pressure
    Diabetes

    Controls Cough
    Relieves Sneezing & Runny Nose

    4 FL. OZ. (118 mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON BOTTLE IS BROKEN OR MISSING.

    K0519

    www.kramerlabs.com ● www.safetussin.com
    © 2019 Kramer Laboratories, Inc. Bridgewater, NJ 08807

    label
  • INGREDIENTS AND APPEARANCE
    SAFETUSSIN   PM
    dextromethorphan doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-173
    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
    Aspartame (UNII: Z0H242BBR1)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    menthol (UNII: L7T10EIP3A)  
    methylparaben (UNII: A2I8C7HI9T)  
    MINT (UNII: FV98Z8GITP)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55505-173-331 in 1 CARTON02/09/2017
    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 finalpart34102/09/2017
    Labeler - Kramer Laboratories (122720675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmecuticals001207208manufacture(55505-173)