FDA Label for Tusslin
View Indications, Usage & Precautions
Tusslin 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.
Drug Facts
Active Ingredients(In Each 5 Ml 1 Teaspoonful)
Dextromethorphan HBr 20 mg
Guaifenesin 388 mg
Phenylephrine HCl 10 mg
Purpose
Cough suppressant
Expectorant
Nasal decongestant
Uses
• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
• helps loosen phlegm (mucus) and thin bronchial secretions to 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 • cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• do not take more than 6 doses in any 24-hour period
• mL = milliliter, tsp = teaspoon
| adults and children 12 years of age and over | 5 mL (1 teaspoon) every 4 hours |
| children under 12 years of age | do not use |
Other Information
• tamper evident feature: do not use if printed security seal is torn, broken or missing.
• store at controlled room temperature 15-30°C (59-86°F) • avoid excessive heat or humidity.
Inactive Ingredients
citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium chloride, sodium citrate, sucralose
Questions Or Comments?
1-787-767-2072
You may also report serious side effects to this phone number.
Call weekdays from 8:00 am to 4:00 pm AST
Packaging
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