FDA Label for Desgen Dm

View Indications, Usage & Precautions

Desgen Dm Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Novis. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 5 Ml Tsp)



Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Phenylephrine HCL, 5mg


Purpose



Cough Suppressant

Expectorant

Nasal Decongestant


Otc - Keep Out Of Reach Of Children



Keep out of reach of children,In case of accidental overdose, get medical help or contact a Poison Control Center right away.


Uses



• Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make   coughs more productive
• temporarily relieves nasal congestion due to a cold


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 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
• diabetes • heart disease • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product do not use more than directed

Stop use and ask a doctor if
• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.


Directions



Do not take more than 6 doses in any 24-hour period


Every 4 hours
Adult and Children 12 years of age and over           10 mL (2 tsp)
Children 6 to under 12 years of age                         5 mL (1 tsp)
Children under 6 years of age                                Consult physician


Inactive Ingredients



Citric Acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.


Other Information



• Tamper evident feature: Do not use if inner seal is torn, broken or missing.
• Store at controlled room temperature 15-30°C (59-86°F).
• Avoid excessive heat or humidity


Other



Manufactured in the USA for Kramer Novis, San Juan, PR 00917, Tel (787) 767-2072 / www.kramernovis.com


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