FDA Label for Tusnel C
View Indications, Usage & Precautions
Tusnel C Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical 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 5 ml tsp.) Purpose
Codeine Phosphate ................................................. 10 mg .......... Cough SuppressantGuaifenesin .......................................................... 100 mg .................. Expectorant
Pseudoephedrine HCl ............................................. 30 mg .......... Nasal Decongestant
Otc - Purpose
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves: nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis, cough due to minor bronchial irritation as may occur with the common cold
- temporarily restores freer breathing through the nose
- calms the cough control center and relieves coughing
Warnings
WarningsDo not use if you are now taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your prescription drug contains anMAOI, ask a doctor or pharmacist before taking this product.When using this productdo nol exceed recommended dosage• may cause or aggravate constipation
Otc - Do Not Use
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. chronic pulmonary disease or shortness of breath, or who are taking other drugs 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 more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical helpor 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: Follow dosage chart
Dosage may be repeated every 6 hours. Not to exceed 4 doses in 24-hours. Giving a higher dose
than recommended by a doctor could result in serious side effects for your child. A special measuring
device should be used to give an accurate dose of this product to children under 6 years of age.
| Age | Weight | Dose |
| children 12 years of age and over | 95 lbs and up | Take 2 teaspoonfuls (10 mL) every 6 hours |
| Children 6 to under 12 years of age | 45 lbs to under 95 lbs | Take 1 teaspoonful (5mL) every 6 hours |
| Children under 6 years of age | under 45 lbs | ask a doctor |
Indications & Usage
Other information
- store at controlled room temperature 20°- 25°C (68°- 77°F)
- Each teaspoonful (5 ml) contains: sodium 2mg
- Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.
Inactive Ingredient
Inactive ingredients aspartame, citric acid, glycerine, methylparaben,natural and artificial flavors, potassium citrate, potassium sorbate,propylene glycol, propylparaben, purified water.
Otc - Questions
Questions or Comments? 1-866-595-5598
* Please review the disclaimer below.