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

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.

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ExeFen IR Tablets

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

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

When using this product

do not exceed the recommended dosage

Stop use and ask a doctor if

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

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:68047-157
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
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; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/10/2011 09/30/2015
Labeler - Larken Laboratories, Inc. (791043719)

Revised: 4/2015
Document Id: 13133ef3-71b4-4222-e054-00144ff8d46c
Set id: ae7986a1-46ad-463c-9b6f-5ec65393df10
Version: 3
Effective Time: 20150406
 
Larken Laboratories, Inc.