SudaTex G IR

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg, PSEUDOEPHEDRINE HYDROCHLORIDE 40mg
Labeler: Larken Laboratories, Inc.
NDC Code: 68047-244

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 G IR

Drug Facts

Active Ingredients (per tablet)

Guaifenesin 400 mg
Pseudoephedrine HCl 40 mg

Purpose

Guaifenesin                                     Expectorant
Pseudoephedrine HCl                   Decongestant

DESCRIPTION

SudaTex G Tablets are white, capsule shaped, scored tablets debossed LL Bisect 243 on one side and plain on the other.

Uses

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

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 the common cold. Reduces swelling of the nasal passages and temporarily relieves sinus congestion and pressure.

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.

Warnings

Do not exceed the recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.  If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough which may occur with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Pseudoephedrine is banned and tested for by the U.S.O.C.

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 Center right away.

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

Directions
Adults and children 12 years of age and over: 1 tablet every 6 hours, not to exceed 4 tablets in a 24 hour period.
Children 12 years of age and younger: Consult a physician.

Other Information

Tamper evident: do not use if tamper evident seal is broken or missing. Store at 20°-25°C (68°-77°F)

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.

Manufactured for:

Larken Laboratories, Inc.

Canton, MS 39046

Principal Display Panel

Figure 1: Container Label

SUDATEX G IR 
guaifenesin and pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-244
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE40 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 LL243
Contains    
Packaging
#Item CodePackage Description
1NDC:68047-244-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/10/201111/30/2012
Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

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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