Label: EXEFEN IR - guaifenesin and pseudoephedrine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 68047-157-01
  • Packager: Larken Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients (in each tablet )

    Guaifenesin, USP                             400 mg

    Pseudoephedrine HCl, USP              60 mg

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  • Purpose

    Guaifenesin, USP                               Expectorant

    Pseudoephedrine HCl, USP             Nasal decongestant

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  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves nasal congestion due to:
      • common cold
      • hay fever
      • upper respiratory allergies (allergic rhinitis)
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • temporarily relieves sinus congestion and pressure
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  • 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 two 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 drug.

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  • Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by excessive phlegm (mucus)
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  • When using this product

    do not exceed the recommended dosage

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  • 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.
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of the reach of children.

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

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  • Directions

    • Do not exceed 4 doses in a 24 hour period
    • Adults and children 12 years of age and over: 1 tablet every 4 hours.
    • Children 6 to under 12 years of age: 1/2 tablet every 4 hours.
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  • Other information

    • store at 20°- 25°C (68°- 77°F)
    • tamper evident: do not use if foil seal under the cap is broken or missing.
    • contains 4 mg sodium in each tablet
    • contains less than 1 mg magnesium in each tablet
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  • Inactive Ingredients

    croscarmellose sodium, magnesium stearate (veg), microcrystalline cellulose, povidone, sodium starch glycolate and starch.

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  • Questions or Comments

    Call 1-888-527-5522 weekdays from 9 AM to 4 PM CST or go to http://www.larkenlabs.com

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  • Package Label

    100 ct Label Rev. 11/2012

    67e35b1d-figure-01

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  • INGREDIENTS AND APPEARANCE
    EXEFEN IR 
    guaifenesin and pseudoephedrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68047-157
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE K30  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STARCH, CORN  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape CAPSULE Size 18mm
    Flavor Imprint Code LL157
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68047-157-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/10/2011
    Labeler - Larken Laboratories, Inc. (791043719)
    Establishment
    Name Address ID/FEI Business Operations
    Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE(68047-157)
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