Manufactured for: Manufactured by:
Laser Pharmaceuticals, LLC Great Southern Laboratories
Greenville, SC 29615 Houston, TX 77099

Rev. 09/09

Principal Display Panel and Side Panel for 15 mL Label:

NDC: 16477-136-15

Donatuss DC
Syrup
Rx

Antitussive
Decongestant
Expectorant

Each 5 mL (1 teaspoonful) contains:
Dihydrocodeine Bitartrate* .. 7.5 mg
(*Warning: May be habit forming)
Phenylephrine HCl ............. 7.5 mg
Guaifenesin........................ 50 mg

Rx Only 15 mL (1/2 fl oz)

See product foldout for full prescribing information.

Store at controlled room temperature, 15o-30oC (59o-86oF).

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

Supplied in a tight, light-resistant container as defined in the USP/NF with a
child-resistant closure.

WARNING: Keep this and all drugs out of the reach of children.

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

Manufactured by:
Great Southern Laboratories
Houston, TX 77099 Rev. 09/09

Professional Sample: Not For Sale

DONATUSSDC
dihydrocodeine bitartrate, phenylephrine hydrochloride, guaifenesin syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16477-136
Route of Administration ORAL DEA Schedule CIII
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dihydrocodeine Bitartrate(Dihydrocodeine) Dihydrocodeine Bitartrate 7.5mg in5mL
Phenylephrine Hydrochloride(Phenylephrine) Phenylephrine Hydrochloride 7.5mg in5mL
Guaifenesin(Guaifenesin) Guaifenesin 50mg in5mL
 
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
 
Product Characteristics
Color  Score 
Shape  Size 
Flavor GRAPE Imprint Code 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 16477-136-16 473mLIn1BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other  10/07/2009 

Labeler -Laser Pharmaceuticals LLC(614417132)
Registrant -Great Southern Laboratories (056139553)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories  056139553 manufacture