Fruit Gum Flavor
Alcohol Free / Gluten Free
Sugar Free / Dye Free

CIII
Rx Only

Distributed by:
Poly Pharmaceuticals
Mobile, AL 36619

16 fl oz. (473 mL)

Side Panel:

DOSAGE AND ADMINISTRATION*: Adults and Children 12 years of age and older:
1 teaspoonful every 4 to 6 hours. Not to exceed 6 teaspoonfuls in a 24 hour period.
Children 6 to 12 years of age: 1/2 teaspoonful every 4 to 6 hours. Not to exceed 3
teaspoonfuls in a 24 hour period.
Not recommended for children under 6 years of age.

*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be
appropriate and adequate.

Refer to the attached 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.

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

This bottle is not to be dispensed to consumer.

Storage: Store at 20o-25oC (68o-77oF); excursions permitted to 15o-30oC (59o-86oF).
[See USP Controlled Room Temperature.] Protect from freezing.

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

Rx Only

Manufactured by: Great Southern Laboratories, Houston, TX 77099

Distributed for: Poly Pharmaceuticals, Mobile, AL 36619

Iss. 09/09

POLY HISTDHC
dihydrocodeine bitartrate, phenylephrine hydrochloride, pyrilamine maleate liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50991-521
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
Pyrilamine Maleate(Pyrilamine) Pyrilamine Maleate 7.5mg in5mL
 
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
 
Product Characteristics
Color  Score 
Shape  Size 
Flavor BUBBLE GUM Imprint Code 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 50991-521-16 473mLIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other  11/12/2009 

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