Medication Guide App

Donatussin DM Drops DM

Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 1.0mg in 1.0mL, Dextromethorphan Hydrobromide 3.0mg in 1.0mL, Phenylephrine Hydrochloride 1.5mg in 1.0mL
Labeler: Laser Pharmaceuticals, LLC
NDC Code: 16477-811

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.

Donatussin DM DROPS

Active ingredients (in each 1 mL dropperful)
Chlorpheniramine Maleate 1.0 mg
Dextromethorphan Hydrobromide 3.0 mg
Phenylephrine Hydrochloride 1.5 mg

PurposeAntihistamine
Antitussive (cough suppressant)
Nasal Decongestant

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • 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 istaking sedatives or tranquilizers.

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

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 informationStore at 59° -86°F (15° -30°C)

Inactive ingredientsCitric Acid, FD and C Red #40, Fruit Gum Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

Questions? Comments?Call a doctor for medical advice about side effects.  Serious side effects associated with use of this product may be reported to this number.
1-864-286-8229 (Mon-Fri) 8am-5pm EST

PRODUCT PACKAGING:The packaging below represents labeling currently used:

Principal Display Panel and Side Panel for 30 mL Label:

NDC 16477-811-30

Donatussin DM DROPS

Antihistamine
Antitussive
Nasal Decongestant

Sugar Free / Alcohol Free

Each dropperful (1.0 mL) contains:
Chlorpheniramine Maleate....................1.0 mg
Dextromethorphan HBr.........................3.0 mg
Phenylephrine HCl...............................1.5 mg

1 fl oz(30 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is missing or broken.

Supplied in a tight, light-resistant container with a child-resistant closure.

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC  29615                                 Rev. 04/10






DONATUSSIN DM DROPS  DM
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-811
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate1.0 mg  in 1.0 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide3.0 mg  in 1.0 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride1.5 mg  in 1.0 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:16477-811-301 BOTTLE (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/20/2005
Labeler - Laser Pharmaceuticals, LLC (614417132)

Revised: 12/2010
 
Laser Pharmaceuticals, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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