G-tuss-nl Ped
FDA Label NDC 43913-406

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 Ped (NDC 43913-406). 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 - ask doctor, otc - do not use, otc - ask doctor/pharmacist, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active Ingredients (in each 5 mL, teaspoonful)Purpose
Guaifenesin 50 mgExpectorant
Dextromethorphan HBr 5 mgCough Suppressant
Pseudoephedrine HCI 15 mgNasal 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 age2 teaspoonfuls (10 mL) every 4 hours
Children 2 to under 6 years of age1 teaspoonful (5 mL) every 4 hours
Children under 2 years of ageConsult 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

Principal Display Panel (473 mL Bottle Label)

Principal Display Panel (473 mL Bottle Label)

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