This bottle is not to be dispensed to consumer.

Rx Only

Manufactured by: Great Southern Laboratories, Houston, TX 77099

Distributed for: Poly Pharmaceuticals, Mobile, AL 36619

Iss. 09/09

Principal Display Panel and Side Panel for 15 mL Label:

NDC 50991-529-15

POLY-TUSSIN EX

Antitussive / Decongestant / Expectorant

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

Grape Flavor
Alcohol Free / Gluten Free
Sugar Free / Dye Free
Rx Only
CIII
Professional Sample: Not For Sale
1/2 fl oz (15 mL)

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

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

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

Manufactured by: Great Southern Laboratories, Houston, TX 77099

Distributed for: Poly Pharmaceuticals, Mobile, AL 36619

Iss. 10/09

Side Panel:

Adults and children over 12 years:
1 to 2 teaspoonfuls (5 mL to 10 mL), every 4 to 6 hours, as needed.
Children 6 to under 12 years of age:
1/2 to 1 teaspoonful (2.5 mL to 5 mL), every 4 to 6 hours, as needed.
Not recommended for children under 6 years of age.
See package insert for full prescribing information.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE
OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT
A POISON CONTROL CENTER IMMEDIATELY.

POLY-TUSSINEX
dihydrocodeine bitartrate, phenylephrine hydrochloride, and guaifenesin syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50991-529
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 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 50991-529-16 473mLIn1BOTTLE None
2 50991-529-15 15mLIn1BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other  11/16/2009 

Labeler -Poly Pharmaceuticals, Inc.(198449894)
Registrant -Great Southern Laboratories (056139553)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories  056139553 manufacture