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G-Tuss-NL

Medically reviewed on Apr 23, 2018

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 10mg in 5mL, Guaifenesin 200mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL
Labeler: McLaren Medical
NDC Code: 43913-404

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

G-Tuss-NL

Drug Facts

Active Ingredients (in each 5 mL, teaspoonful)Purpose
Guaifenesin 200 mgExpectorant
Dextromethorphan HBr 10 mgCough Suppressant
Pseudoephedrine HCl 30 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.

Warnings

  • 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.

  • 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.

  • 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.

  • 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.

  • If pregnant or breast-feeding, ask a health professional before use.

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

  • 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 over2 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

G-TUSS-NL 
dextromethorphan hydrobromide, guaifenesin, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43913-404
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin200 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate 
Citric Acid Monohydrate 
Sorbitol 
Saccharin Sodium 
Sucralose 
Propylene Glycol 
Water 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:43913-404-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/11/2014
Labeler - McLaren Medical (013770591)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIOperations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(43913-404), PACK(43913-404), LABEL(43913-404), ANALYSIS(43913-404)

 
McLaren Medical

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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