G-Tuss-NL: Package Insert and Label Information

G-TUSS-NL- dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride liquid
McLaren Medical

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.

Drug Facts

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.

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 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
(click image for full-size original)
G-TUSS-NL
dextromethorphan hydrobromide, guaifenesin, and pseudoephedrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43913-404
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 200 mg in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 30 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Benzoate
Citric Acid Monohydrate
Sorbitol
Saccharin Sodium
Sucralose
Propylene Glycol
Water
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43913-404-16 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 02/11/2014
Labeler — McLaren Medical (013770591)
Registrant — davAgen Pharmaceutical, LLC (967545935)
Establishment
Name Address ID/FEI Operations
davAgen Pharmaceutical, LLC 967545935 MANUFACTURE (43913-404), PACK (43913-404), LABEL (43913-404), ANALYSIS (43913-404)

Revised: 04/2014 McLaren Medical

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