Other
Drug Facts
- In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
G-tuss-nl
FDA Label NDC 43913-404
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mclaren Medical for the product G-tuss-nl (NDC 43913-404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, indications, otc - stop use, otc - ask doctor, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients (in each 5 mL, teaspoonful) | Purpose |
|---|---|
| Guaifenesin 200 mg | Expectorant |
| Dextromethorphan HBr 10 mg | Cough Suppressant |
| Pseudoephedrine HCl 30 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 - Stop Use
- Do not exceed recommended dosage.
If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.
Otc - Ask 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 take this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
- 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.
- Do not take this product for persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Otc - Pregnancy Or Breast Feeding
- If pregnant or breast-feeding, ask a health professional before use.
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.
| Adults and children 12 years of age and over | 2 teaspoonfuls (10 mL) every 4 hours |
| Children 6 to under 12 years of age | 1 teaspoonful (5 mL) every 4 hours |
| Children under 6 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-43913-404-16
G-Tuss-NL
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
Principal Display Panel (473 mL Bottle Label)
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