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SUDATEX — DM — 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.

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

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helps loosen phlegm (mucus)

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nasal congestion

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thin bronchial secretions

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drain bronchial tubes

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make coughs more productive

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stuffy nose

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clear nasal passageways

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shrinks swollen membranes

Warnings

Do not use more than the recommended dosage

Do not use

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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

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heart disease

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excessive phlegm (mucus)

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high blood pressure

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diabetes

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thyroid disease

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difficulty in urination due to enlargement of the prostate gland

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persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

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nervousness, dizziness, or sleeplessness occurs

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symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)

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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

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ask a health professional before use.

Keep out of the reach of children

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In case of accidental overdose, get medical help or contact a Poison Control immediately.

Directions

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

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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.

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Children under 6 years of age: ask a doctor.

Other Information

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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

(click image for full-size original)

Revised: 04/2012 Larken Laboratories Inc.