EXEFEN DMX- dextromethorphan hydrobromide, 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 DMX

Drug Facts

Active Ingredients

(in each immediate-release tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Pseudoephedrine HCl 60 mg

Purpose

Dextromethorphan HBr Antitussive
Guaifenesin Expectorant
Pseudoephedrine HCl Nasal Decongestant

Uses

temporarily relieves

cough due to minor throat or bronchial irritation associated with a cold
cough impulses without narcotics
helps loosen phlegm and thin bronchial secretions to make coughs more productive
nasal congestion

sinus congestion and pressure due to a cold or hay fever

Warnings

Do not exceed recommended dosage.
a persistent cough may be a sign of a serious condition

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

Ask a doctor or pharmacist before use

If you are taking sedatives or tranquilizers

Stop use and ask a doctor if

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache
nervousness, dizziness or sleeplessness 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.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	1 tablet by mouth every 4 to 6 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:	Consult a doctor

Inactive Ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions? Comments?

Call 1-888-527-5522

Principal Display Panel

Figure 1: Container Label

f68b76be-figure-01

Figure 2: Label Text

Figure 3: Label Text

EXEFEN DMX
dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68047-155
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL (Modified)	Size	16mm
Flavor		Imprint Code	LL155
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68047-155-01	100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/28/2011	11/10/2015

Labeler - Larken Laboratories, Inc. (149484540)

Registrant - Larken Laboratories, Inc. (791043719)

Name	Address	ID/FEI	Business Operations
Establishment
TG United, Inc.		172837085	manufacture(68047-155)

Revised: 11/2015

Document Id: 2437a3d3-9c0f-68cc-e054-00144ff88e88

Set id: 65164bf9-8ce6-4aff-b0e1-98ce6de8bfc1

Version: 3

Effective Time: 20151110

Larken Laboratories, Inc.