Label: LIBERA TOS- dextromethorphan hbr, guaifenesin 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 November 1, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients:(in each teaspoonful 5 ml.)                                Purpose

    Dextromethorphan Hydrobromide 10 mg .................................. Cough Suppressant

    Guaifenesin 100 mg ................................................................... Expectorant

  • PURPOSE

    Uses:

    • Temporarily relieves cough due to the common cold or inhaled irritants.
    • Helps loosen mucus and bronchial secretions to make cough more productive.
  • WARNINGS

    Warnings

    Do not use if taking a prescription Monoamine Oxidase Inhibitor(MAOI) (certain drugs for Depression, psychiatric, or emotional condition or parkinson’s desease ), or for 2 weeks after stopping the MAOI Drug. If taking a prescription and do not know if it contains MAOI ask the Doctor before taking this product. Ask a Health Professional before use if: pregnant or breast feeding or suffer Diabetes. Stop use and ask a Doctor: if cough persists more than seven days or if accompanied by fever, rash, or persistant headache, these could be signs of a serious condition or illness.

    Keep out of the reach of children, in case of accidental overdose seek professional assistance or contact a Poison Control Center immediately


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Shake well immediately before each use.

    Do not exceed 6 doses in any 24 hour period.


    AGE
    		DOSES
    Adults and Children 12 years and over
    		10 ml (2 tsps) every 4 hours
    Children 6 to under 12 years of age
    		5 ml (1 tsp) every 4 hours
    Children under 6 years of age
    		Do not  use



  • INDICATIONS & USAGE

    Other Information:Do not use if seal or cap is broken or torn, measure cup is provided
    Store at 20 - 25 ºC (68 - 77 ºF).

  • INACTIVE INGREDIENT

    Inactive Ingredients:Aloe Vera, Caramel color, Citric Acid, Eucalyptus, Pure Honey, Ginger,Honey flavor, Hydroxyethyl cellulose Pharm 250, Menthol, Methylparaben,Potassium Sorbate,Propylene Glycol, Propylparaben, Purified water,Sodium Chloride, Sucralose.

  • QUESTIONS

    Questions or Comments?

    please call: 305-791-8763


    Manufactured by

    Gadal Laboratories, Inc., Miami, Fl 33186

    Exclusively Distributed by

    ROCKHEALTH, INC., Miami, Fl 33018

    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL

    LiberaTos Label

  • INGREDIENTS AND APPEARANCE
    LIBERA TOS 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60840-0100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    HONEY (UNII: Y9H1V576FH)  
    ALOE (UNII: V5VD430YW9)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GINGER (UNII: C5529G5JPQ)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MENTHOL (UNII: L7T10EIP3A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60840-0100-1118 mL in 1 BOTTLE
    2NDC:60840-0100-2178 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2013
    Labeler - RockHealth, Inc (079130011)
    Registrant - RockHealth, Inc (079130011)
    Establishment
    NameAddressID/FEIBusiness Operations
    RockHealth, Inc079130011LABEL(60840-0100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gadal Laboratories Inc841305639MANUFACTURE(60840-0100)
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