POLY-TUSSIN description, usages, side effects, indications, overdosage, supplying and lots more!

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POLY-TUSSIN

Poly Pharmaceuticals, Inc.
Great Southern Laboratories

POLY-TUSSIN EX


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Poly-Tussin EX Syrup

Rx Only
CIII

DESCRIPTION


WARNING













POLY-TUSSIN




POLY-TUSSIN




POLY-TUSSIN

CLINICAL PHARMACOLOGY













POLY-TUSSIN INDICATIONS AND USAGE



POLY-TUSSIN CONTRAINDICATIONS









WARNINGS

General:



Usage in Ambulatory Patients:



Respiratory Depression:








Hypertensive Effect:







Dependence:

Drug Abuse and Dependence

PRECAUTIONS

General:









Drug Interactions:

General:


Other CNS Depressants:





Monoamine Oxidase Inhibitors:


Information for Patients:


  • This product may inhibit mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
  • Report any adverse experiences occurring during therapy.
  • Do not adjust the dose of this product without consulting the prescribing professional.
  • Do not combine this product with alcohol or other central nervous system depressants.
  • Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of opioids and other drug use during pregnancy on themselves and their unborn child.

Pregnancy:

Pregnancy Category C





Nonteratogenic Effects:







Labor and Delivery:



Nursing Mothers:


Pediatric Use:






Geriatric Use:



Hepatic Impairment:



Renal Impairment:


Pacreatic/biliary Tract Disease:

POLY-TUSSIN ADVERSE REACTIONS













DRUG ABUSE AND DEPENDENCE








OVERDOSAGE





Signs and Symptoms:






Recommended Treatment:













POLY-TUSSIN DOSAGE AND ADMINISTRATION

Adults and children over 12 years:
Children 6 to under 12 years of age:

Not recommended for children under 6 years of age.

HOW SUPPLIED





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.



oooo









Rx only






PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL Label:

NDC 50991-529-16

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

CIII

Rx Only

Distributed by:
Poly Pharmaceuticals
Mobile, AL 36619

16 fl oz. (473 mL)

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.

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.

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

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

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)





Storage:
oooo







Side Panel:


Adults and children over 12 years:


Children 6 to under 12 years of age:

Not recommended for children under 6 years of age.


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-TUSSIN
POLY-TUSSIN
POLY-TUSSIN
POLY-TUSSIN
POLY-TUSSIN
POLY-TUSSIN


POLY-TUSSIN

Dihydrocodeine Bitartrate, Phenylephrine Hydrochloride, and Guaifenesin SYRUP

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:50991-529
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dihydrocodeine Bitartrate DIHYDROCODEINE 7.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
Guaifenesin GUAIFENESIN 50 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50991-529-16 473 in 1 BOTTLE
2 NDC:50991-529-15 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-11-16


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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