Your browser does not support JavaScript! EXEFEN IR (GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [LARKEN LABORATORIES, INC.]
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EXEFEN IR (guaifenesin and pseudoephedrine hydrochloride) tablet
[Larken Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Drug Facts

Active Ingredients (in each tablet )

Guaifenesin, USP                             400 mg

Pseudoephedrine HCl, USP              60 mg

Purpose

Guaifenesin, USP                               Expectorant

Pseudoephedrine HCl, USP             Nasal decongestant

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

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.

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)

When using this product

do not exceed the recommended dosage

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

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.

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

Inactive Ingredients

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

Questions or Comments

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

Package Label

100 ct Label Rev. 11/2012

67e35b1d-figure-01

EXEFEN IR 
guaifenesin and pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68047-157
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize18mm
FlavorImprint Code LL157
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68047-157-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/10/2011
Labeler - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIBusiness Operations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(68047-157)

Revised: 11/2012
 
Larken Laboratories, Inc.

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