SUDATEX - DM

Dosage form: tablet
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg, GUAIFENESIN 400mg, PSEUDOEPHEDRINE HYDROCHLORIDE 40mg
Labeler: Larken Laboratories Inc.
NDC Code: 68047-247

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.

SudaTex DM

Drug Facts

Active Ingredients (per tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Pseudoephedrine HCl 40 mg

Purpose

Dextromethorphan HBr                  Antitussive
Guaifenesin                                     Expectorant
Pseudoephedrine HCl                   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 use more than 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 occurs
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 or contact a Poison Control immediately.

Directions
Adults and Children over 12 years of age: 1 tablet every 4-6 hours, not to exceed 6 tablets in a 24 hour period.
Children 6 to under 12 years of age: take 1/2 tablet every 4-6 hours, not to exceed 3 tablets in a 24 hour period.
Children under 6 years of age: ask a doctor.

Other Information
store at 15°-30°C (59°-86°F)
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

Croscarmellose Sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyvinylpyrrolidone, Silica and Stearic Acid.

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.

Distributed by:
Larken Laboratories, Inc.
Canton, MS 39046

Principal Display Panel

Figure 1: Container Label

SUDATEX - DM 
dextromethorphan hbr, guaifenesin, and pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-247
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
CROSPOVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code LL242
Contains    
Packaging
#Item CodePackage Description
1NDC:68047-247-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/22/201101/31/2013
Labeler - Larken Laboratories Inc. (791043719)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp.968334974MANUFACTURE

Revised: 04/2012
 
Larken Laboratories Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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