G-Tuss-NL Ped description, usages, side effects, indications, overdosage, supplying and lots more!

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G-Tuss-NL Ped

McLaren Medical
davAgen Pharmaceutical, LLC

G-Tuss-NL Ped


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

  • 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 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.
  • 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 asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • 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.

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

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

G-Tuss-NL Ped

G-Tuss-NL Ped

Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43913-406
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Guaifenesin GUAIFENESIN 50 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 15 mg

Inactive Ingredients

Ingredient Name Strength
SODIUM BENZOATE
CITRIC ACID MONOHYDRATE
sorbitol
saccharin sodium
Sucralose
propylene glycol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43913-406-16 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-02-11


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Be sure to consult your doctor before taking any medication!
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