G-Tuss-NL Ped

Label at a glance#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

• 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.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

• 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.

OTC - DO NOT USE SECTION

• 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.

OTC - ASK DOCTOR SECTION

• 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 SECTION

• 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 SECTION

• In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep this and all drugs out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Other Information

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

• G-Tuss-NL Ped
• Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride
• Dextromethorphan Hydrobromide
• Dextromethorphan
• Guaifenesin
• Pseudoephedrine Hydrochloride
• Pseudoephedrine
• Sodium Benzoate
• Citric Acid Monohydrate
• Sorbitol
• Saccharin Sodium
• Sucralose
• Propylene Glycol
• Water

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 304 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

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