FDA Label for Tusnel
View Indications, Usage & Precautions
Tusnel Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceuticals International Division. 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.
Otc - Active Ingredient
Active Ingredients (In each tablet) Purpose
Dextromethorphan HBr ................... 30 mg ................... Cough Suppressant
Guaifenesin .................................. 400 mg .................. Expectorant
Pseudoephedrine HCl .................... 60 mg .................... Nasal Decongestant
Otc - Purpose
Uses
- temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
- temporary relief of cough due to minor throat and bronchial irritation
- helps to control reflex that causes coughing
Warnings
Warnings
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to the enlargement of the prostate gland
- a cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or accompanied by fever
- cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache
When using this product do not exceed recommended dosage.
Stop use and ask a doctor if
Otc - Do Not Use
Do not use
- if you are now taking a prescription monamine 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 you are taking a prescription drug that contains on MAOI, ask your doctor or pharmacist before taking this product.
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Dosage & Administration
Directions:Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.
| adults and children 12 years of age and over | take 1 tablet every 6 hours |
| children 6 to under 12 years of age | take 1/2 tablet every 6 hours |
| children under 6 years of age | ask a doctor |
Indications & Usage
Other Information
Store at controlled room temperature 20-25 degrees C (68-77 degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F)
Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering
Inactive Ingredient
Inactive Ingredients: FD and C Blue No. 1, FD and C Blue No. 2, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate type B, titanium dioxide.
Otc - Questions
Questions or Comments? 1-866-595-5598
Package Label.Principal Display Panel
* Please review the disclaimer below.