G-tuss-nl Ped

G-tuss-nl Ped
SPL v1
SPL
SPL Set ID 0c2632f4-edbc-47d4-94ef-af3512520596
Route
ORAL
Published
Effective Date 2014-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (50 mg) Pseudoephedrine (15 mg)
Inactive Ingredients
Sodium Benzoate Citric Acid Monohydrate Sorbitol Saccharin Sodium Sucralose Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-02-11
Description

Drug Facts

Medication Information

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1
  • Keep this and all drugs out of the reach of children.
Section 50568-5
  • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Section 50569-3
  • 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.
Section 50570-1
  • 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.
Section 55105-1
Active Ingredients (in each 5 mL, teaspoonful) Purpose
Guaifenesin 50 mg Expectorant
Dextromethorphan HBr 5 mg Cough Suppressant
Pseudoephedrine HCI 15 mg Nasal Decongestant
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
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.
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.

Inactive Ingredients

Citric Acid, Grape Flavor, Propylene Glycol, Purified Water, Saccharine Sodium, Sodium Benzoate, Sorbitol, Sucralose.

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

Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep this and all drugs out of the reach of children.
Section 50568-5 (50568-5)
  • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Section 50569-3 (50569-3)
  • 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.
Section 50570-1 (50570-1)
  • 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.
Section 55105-1 (55105-1)
Active Ingredients (in each 5 mL, teaspoonful) Purpose
Guaifenesin 50 mg Expectorant
Dextromethorphan HBr 5 mg Cough Suppressant
Pseudoephedrine HCI 15 mg Nasal Decongestant
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
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.
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.

Inactive Ingredients

Citric Acid, Grape Flavor, Propylene Glycol, Purified Water, Saccharine Sodium, Sodium Benzoate, Sorbitol, Sucralose.

Principal Display Panel 473 Ml Bottle Label (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:47.187619 · Updated: 2026-03-14T22:53:44.517550