FDA Label for G-tuss-nl Ped
View Indications, Usage & Precautions
G-tuss-nl Ped Product Label
The following document was submitted to the FDA by the labeler of this product Mclaren Medical. 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.
Other
Drug Facts
Otc - Purpose
Active Ingredients (in each 5 mL, teaspoonful) | Purpose |
---|---|
Guaifenesin 50 mg | Expectorant |
Dextromethorphan HBr 5 mg | Cough Suppressant |
Pseudoephedrine HCI 15 mg | Nasal Decongestant |
Indications
- For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
- Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
- Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants.
- Temporarily helps you cough less.
Otc - Ask Doctor
- Do not exceed recommended dosage.
If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor. - If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
- A persistent cough may be the sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache, consult a doctor.
Otc - Do Not Use
- Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
- Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- Do not take this product for persistent or chronic cough such as occurs with asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Otc - Ask Doctor/Pharmacist
- In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
- Keep this and all drugs out of the reach of children.
Directions
Do not take more than 6 doses in any 24-hour period.
Children 6 to under 12 years of age | 2 teaspoonfuls (10 mL) every 4 hours |
Children 2 to under 6 years of age | 1 teaspoonful (5 mL) every 4 hours |
Children under 2 years of age | Consult a doctor |
Inactive Ingredients
Citric Acid, Grape Flavor, Propylene Glycol, Purified Water, Saccharine Sodium, Sodium Benzoate, Sorbitol, Sucralose.
Other Information
Store at 20°-25°C (68°-77°F)
Tamper evident by seal under cap. Do not use if the seal is broken or missing.
Principal Display Panel - 473 Ml Bottle Label
NDC-43913-406-16
G-Tuss-NL Ped
Cough Suppressant, Expectorant & Nasal Decongestant
Sugar Free • Dye Free • Alcohol Free • Phenylalanine Free
Grape Flavor
16 FL OZ (473 mL)
Multiple Dose Unit Package
For Dispensing Under Pharmaceutical Supervision Only
McLaren Medical
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