Donatussin DROPS

Dosage form: liquid
Ingredients: Phenylephrine Hydrochloride 1.5mg in 1.0mL, Guaifenesin 20.0mg in 1.0mL
Labeler: Laser Pharmaceuticals, LLC
NDC Code: 16477-106

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 DROPS

Active ingredients (in each 1 mL dropperful)
Phenylephrine Hydrochloride 1.5 mg
Guaifenesin 20.0 mg

PurposeNasal Decongestant
Expectorant

Usestemporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings Do not exceed recommended dosage.

Do not use this product
  • if you or your child are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug.  If you do not know if you child's or your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product or giving it to your child.

Ask a doctor before use if you or your child has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with asthma

Ask a doctor or pharmacist before use if you or your child aresedatives or tranquilizers.

When using this product
  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedative, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occurs
  • if symptoms do not get better within 7 days or are accompanied by a fever.
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

If pregnant or breast-feeding,ask a health professional before use.

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 enclosed dropper only.  Do not use any other dosage device.

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


Other informationStore at controlled room temperature 59° -86°F (15° -30°C)
[see USP Controlled Room Temperature].

Inactive ingredientsCitric Acid, Sodium Citrate, Sodium Saccharin, Sorbitol 70% Solution, Glycerin 99.5% minimum, Propylene Glycol, Raspberry Flavor, FD and C Red #40, Purified Water.

Questions? Comments?Call your doctor for medial 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 PACKAGINGThe packaging below represents labeling currently used:

Principal Display Panel and Side Panel for 30 mL Label:

NDC 16477-106-30

Donatussin DROPS

Nasal Decongestant
Expectorant

Sugar Free / Alcohol Free

Raspberry Flavored

Each dropperful (1.0 mL) for oral administration, contains:
Phenylephrine HCl.......................1.5 mg
Guaifenesin...............................20.0 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. 06/10







DONATUSSIN DROPS 
phenylephrine hydrochloride, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16477-106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride1.5 mg  in 1.0 mL
Guaifenesin (Guaifenesin) Guaifenesin20.0 mg  in 1.0 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Glycerin 
Propylene Glycol 
Water 
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:16477-106-301 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.

Hide
(web4)