FDA Label for Tusnel Pediatric DM
View Indications, Usage & Precautions
Tusnel Pediatric DM Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division, Inc.. 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
In each 5 mL
Dextromethorphan HBr - 5 mg
Guaifenesin - 75 mg
Phenylephrine HCl - 2.5 mg
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Indications & Usage
Uses
- temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
- helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold
Warnings
Warnings
Do not use if your child is taking a 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if your child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargment of prostate gland
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
- taking sedatives, tranquilizers or drugs for depression or MAOI drugs. Stop use and ask a doctor if your child gets
- nervousness, dizziness, or sleeplessness occur
- cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition.
Ask a doctor before use if your child is
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a doctor before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.
Dosage & Administration
Directions: Do not exceed 6 doses in 24 hour
| Age | Dose |
| Children 6 to under 12 years of age | Take 2 teaspoonful (10 mL) every 4 hours |
| Children 2 to under 6 years of age | Take 1 teaspoonful (5 mL) every 4 hours |
| Children under 2 years of age | Ask a doctor |
Inactive Ingredient
Inactive ingredients: artificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.
Otc - Questions
Questions or Comments? 1-866-595-5598
Package Label.Principal Display Panel
* Please review the disclaimer below.
