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

Donatussin DM Drops

Laser Pharmaceuticals, LLC

  • 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
Donatussin DM DROPS

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

(in each 1 mL dropperful)



Purpose




Uses


  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • swelling of nasal passages
  • runny nose
  • sneezing
  • itchy, water eyes
  • itching of the nose or throat

Warnings

Do not exceed recommended dosage.

Do not use this product

  • if your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • a cough that lasts or is chronic such as occurs with asthma
  • a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if your child is


When using this product

  • may cause marked drowsiness
  • sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  These could be signs of a serious condition.

Keep out of the reach of children.


Directions

  • Do not exceed recommended dosage.
  • Use only with enclosed dropper.  Do not use with any other dosing device.

Children 6 to under 12
years of age:
2 dropperfuls (2 mL) every 4-6 hours, not
to exceed 6 doses in 24 hours
Children under 6
 years of age:
Consult a Doctor


Other information


Inactive ingredients


Questions? Comments?



PRODUCT PACKAGING:































PRODUCT PACKAGING:
PRODUCT PACKAGING:

PRODUCT PACKAGING:

Donatussin DM Drops

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16477-811
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 1.0 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 3.0 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 1.5 mg

Inactive Ingredients

Ingredient Name Strength
Citric acid
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:16477-811-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-12-20


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