EXEFEN IR  - guaifenesin and pseudoephedrine hydrochloride tablet 
Larken Laboratories, Inc.

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ExeFen IR

Drug Facts

Active Ingredients (per tablet)

Guaifenesin 400 mg
Pseudoephedrine HCl 60 mg

Purpose

Guaifenesin                                     Expectorant
Pseudoephedrine HCl                   Nasal Decongestant

Uses

Temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies

• helps loosen phlegm (mucus)
• nasal congestion
• thin bronchial secretions
• drain bronchial tubes
• make coughs more productive
• stuffy nose
• clear nasal passageways
• shrinks swollen membranes

Warnings

Do not exceed the 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Ask a doctor before use if you have

• heart disease
• excessive phlegm (mucus)
• high blood pressure
• diabetes
• thyroid disease
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)
• cough and congestion do not improve within 7 days or tend to recur

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 accidental overdose, get medical help right away.

Directions

• Adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours as needed. Do not exceed 4 tablets in a 24 hour period.
• Children 6 to under 12 years of age: take 1/2 tablet every 4 to 6 hours as needed. Do not exceed 2 tablets in a 24 hour period.
• Children under 6 years of age: ask a doctor

Other Information

Store at 20°-25°C (68°-77°F)

Inactive Ingredients

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

Questions or Comments?

Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

Principal Display Panel

Figure 1: Container Label

Figure 2

EXEFEN IR  guaifenesin and pseudoephedrine hydrochloride   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 68047-157-01 100 TABLET In 1 BOTTLE None

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)

Registrant - Larken Laboratories, Inc. (791043719)

Establishment
Name	Address	ID/FEI	Operations
Sovereign Pharmaceuticals, LLC		623168267	MANUFACTURE

Revised: 01/2011Larken Laboratories, Inc.