DONATUSSIN DM DROPS DM- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid 
Laser Pharmaceuticals, LLC

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

Purpose

Antihistamine

Antitussive (cough suppressant)

Nasal Decongestant

Uses

temporarily 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 is

taking 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 information

Store at 59° -86°F (15° -30°C)

Inactive ingredients

Citric 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 Packaging
Donatussin DM DROPS Packaging
Donatussin DM DROPS Packaging

DONATUSSIN DM DROPS  DM
chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-811
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE3 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16477-811-301 in 1 CARTON12/20/200507/03/2017
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/20/200507/03/2017
Labeler - Laser Pharmaceuticals, LLC (614417132)

Revised: 11/2017
 
Laser Pharmaceuticals, LLC