Tusnel DM description, usages, side effects, indications, overdosage, supplying and lots more!

Tusnel DM

Llorens Pharmaceutical International Division

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts



FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients in each 1 mL (dropperful)                    Purpose

Dextromethorphan HBr........ 2.5 mg.......................................... Cough suppressant

Guaifenesin........................25mg................................................Expectorant

Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant



Purpose

Uses
  • Temporary relief of cough due to minor throat and
    bronchial irritation.
  • Temporarily relieves nasal congestion due to
    the common cold and thin bronchial secretions to make coughs
    more productive.
  • helps loosen phlegm (mucus) and thin bronchial
    secretions to make cough more productive.


Warnings

Do not use in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if your child has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with asthma

When using this product
  • do not exceed recommended dosage
Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not get better within 7 days or accompanied by fever
  • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Uses


Other information
  • store at controlled room temperature 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature]
  • Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering
  • Oral dosing device enclosed

Inactive ingredients citric acid, D and C Red Number 33,FD and C Blue #1, flavor, glycerin, propylene glycol, sodium benzoate, sodium saccharin, water.
Questions or Comments? 1-866-595-5598
Directions Do not exceed more than 4 doses in any 24-hour periodor as directed by a doctor.
Age
Weight Dose
Children 2 to under
6 years of age
24 -47 lbs
 Take 2 mL (two dropperfuls)
 every 4 to 6 hours
Children under 2 years of age
Under 24 lbs
 ask a doctor

Tusnel DM

Dextromethorphan, Guiafenesin, Pseudoephedrine HCl SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54859-603
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 25 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 7.5 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 2.5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
CITRIC ACID MONOHYDRATE
GLYCERIN
SODIUM BENZOATE
saccharin sodium
propylene glycol
water
D&C RED NO. 33

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54859-603-02 60 in 1 BOTTLE, DROPPER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1993-01-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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