Label: LORTUSS EX- codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid

  • NDC Code(s): 69036-130-16
  • Packager: Sallus Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • 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 August 29, 2014

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

  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)
    Codeine Phosphate 10 mg
    Guaifenesin 100 mg
    Pseudoephedrine Hydrochloride 30 mg

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  • Purpose

    Cough Suppressant
    Expectorant
    Nasal Decongestant

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  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • nasal congestion
    • reduces swelling of nasal passages
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  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • 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

    • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    When using this product

    May cause or aggravate constipation

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
    • new symptoms occur

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of the reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

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  • Directions

    Do not exceed recommended dosage.

     Adults and children
     12 years of age and over:           
     2 teaspoonfuls (10 mL) every
     4 hours, not to exceed
     8 teaspoonfuls in a 24-hour
     period or as directed by a doctor
     Children 6 to under
     12 years of age:
     1 teaspoonful (5 mL) every
     4 hours, not to exceed
     4 teaspoonfuls in a 24-hour
     period or as directed by a doctor
     Children under 6 years of age:
     Consult a doctor

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  • Other information

    Store at 59o- 86oF (15o- 30oC)

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  • Inactive ingredients

    Apple Cinnamon Flavor, Citric Acid, Glycerin, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

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  • Questions? Comments?

    Serious side effects associated with use of this product may be reported to this number. Call 1-205-314-4780
    Mon-Fri (8 a.m. to 5 p.m. CST)                              Iss. 06/14     

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel
    NDC 69036-130-16
    LORTUSS EX
    Antitussive / Expectorant / Decongestant
    Each 5 mL (1 teaspoonful) contains:
    Codeine Phosphate*................... 10 mg
    *(WARNING: May be habit forming)
    Guaifenesin.............................. 100 mg
    Pseudoephedrine HCl................ 30 mg
    Apple Cinnamon Flavor

    Alcohol Free / Sugar Free
    Dye Free

    CV
    16 fl. oz. (473 mL)

    NDC 69036-130-16 LORTUSS EX Antitussive / Expectorant / Decongestant Each 5 mL (1 teaspoonful) contains: Codeine Phosphate*................... 10 mg *(WARNING: May be habit forming) Guaifenesin.............................. 100 mg Pseudoephedrine HCl................ 30 mg Apple Cinnamon Flavor Alcohol Free / Sugar Free Dye Free CV 16 fl. oz. (473 mL)

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  • INGREDIENTS AND APPEARANCE
    LORTUSS  EX
    codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69036-130
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE 10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor APPLE (Apple Cinnamon Flavor) , CINNAMON (Apple Cinnamon Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69036-130-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 06/01/2014
    Labeler - Sallus Laboratories, LLC (079418254)
    Establishment
    Name Address ID/FEI Business Operations
    TG United Liquid, Inc. 830980947 MANUFACTURE(69036-130)
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