SORBUTUSS NR- sorbutuss liquid

Sorbutuss by

Drug Labeling and Warnings

Sorbutuss by is a Otc medication manufactured, distributed, or labeled by Teral,Inc, Teral Inc, Dextrum Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Active Ingredients

    Each 7.5 mL. Contains (1 1/2 tsp)

    Dextromethorphan HBr 15 mg......Antitussive

    Glyceryl Guaiacolate 150 mg....Expectorant

    Purpose Section

    Antitusive

    Expectorant

  • These highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval

    • For the temporary relief of cough due to minor throat and bronchial irritation as may occur with a cold.
    • Helps loosen phlegm (mucus) and thin bronchial secretions to makes cough more productive.
  • 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.

  • Ask A Doctor Before use if you have

    • Chronic cough that last such as occurs with smoking, asthma, chronic bronchitis or emphysema.
    • Cough that occurs with too much phlegm (mucus).
  • Stop use and ask a doctor if

    • Cough last for more than 7 days comes back or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • Pregnancy or breast feeding section

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

  • Keep out of reach of children

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

  • These highlights do not include all the information needed to use

    Follow dosage below or use as directed by a doctor. Do not exceed 6 doses in a 24 hours period.

    Adults and children 12 years and older 2 teaspoonfuls every 4 hours

    Children 6 years to under 6 years 1 teaspoonful every 4 hours

    Children 2 years to 6 years 1/2 teaspoonful every 4 hours

    Children under 2 years Consult a doctor

  • Other information

    Store at room temperature 15º-30º C (59º - 86º F)

  • Inactive Ingredients

    Artificial and Natural Flavors, Glycerin, Methylparaben, Potassium Citrate, Propylparaben, Purified Water, Sorbitol and Sucralose

  • Questions or Comments?

    Teral, Inc. (787) 383-2781 Fax (787) 284-9082

  • Safety Information

    Do not accept if safety seal around bottle cap is broken or missing

  • Expiration Date information

    Lot:

    Exp:

    Rev:12/06

  • Principal Panel

    Sorbutuss

    NDC: 68436-120-16

    Sorbutuss NR

    Antitussive-Expectorant

    Does Not Containt

    Antihistamines

    Decongestants

    Sodium

    With

    Sucralose

    Sugar Free Alcohol Free

    Dye Free

    Grape Flavor

    16 oz. fl. oz. (474 mL)

    Manufacture for

    Teral, Inc.

    Ponce, P.R. 00731

  • INGREDIENTS AND APPEARANCE
    SORBUTUSS  NR
    sorbutuss liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68436-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGE (with Sucralose) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 68436-120-16474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2007
    Labeler - Teral Inc. (186958810)
    Registrant - Teral Inc (186958810)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories, Inc007392322manufacture(68436-120)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teral, Inc186958810label(68436-120)

  • Trademark Results [Sorbutuss]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SORBUTUSS
    SORBUTUSS
    74286313 not registered Dead/Abandoned
    Cococare Products, Inc.
    1992-06-19
    SORBUTUSS
    SORBUTUSS
    74136469 not registered Dead/Abandoned
    Richmond Pharmacy Products, Inc.
    1991-02-05
    SORBUTUSS
    SORBUTUSS
    74047512 not registered Dead/Abandoned
    Cococare Products, Inc.
    1990-04-10
    SORBUTUSS
    SORBUTUSS
    72154213 0753615 Dead/Expired
    DALIN PHARMACEUTICALS, INC.
    1962-10-01

    © 2021 FDA.report
    This site is not affiliated with or endorsed by the FDA.