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Poly Hist CB

Generic Name: carbetapentane citrate and guaifenesin
Dosage Form: liquid

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Poly Hist CB

Poly Hist CB

Antitussive/Expectorant
Rx Only

Description: Poly Hist CB is an alcohol-free, sugar-free, purple liquid for oral administration
having a grape odor and flavor.

Each Teaspoon (5 mL) Contains:

CARBETAPENTANE CITRATE............................ 20 mg
GUAIFENESIN ....................................................75 mg

Poly Hist CB Liquid also contains: FD and C Blue #1, FD and C Red #40, Grape Flavor, Maltitol,
Propylene Glycol, Sodium Saccharin, Sorbitol, Purified Water.

Clinical Pharmacology:

Carbetapentane citrate is a centrally acting non-narcotic antitussive.

Guaifenesin is an expectorant. Its action increases the output of respiratory tract fluid by reducing
adhesiveness and surface tension. Sinus and bronchial drainage is improved and dry, nonproductive
coughs become more productive and less frequent.

Indications And Usage:

for temporary relief of non-productive cough accompanying respiratory tract congestion associated with
the common cold, influenza, sinusitis, and bronchitis.

Contraindications:

Poly Hist CB is contraindicated in infants and newborns, and in patients with a known
hypersensitivity to any of the components. It is also contraindicated in patients on MAO inhibitor therapy.

Warnings:

A persistent cough may be a sign of a serious condition. If cough persists for more than one week
or tends to recur, or is accompanied by fever, rash, or persistent headache, patient reevaluation
should be considered.

Precautions:

DRUG INTERACTIONS: Guaifenesin may produce an increase in urinary 5-hydroxy-indoleacetic acid and
may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may
also falsely elevate the VMA test for catechols. Administration of this drug should be discontinued 48 hours
prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, And Impairment of Fertility:

No adequate and well controlled studies have been conducted to determine whether the components
of Poly Hist CB have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Pregnancy Category C: Animal reproduction studies have not yet been conducted with this product.
It is not known whether it can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. This product should not be administered to pregnant women.

Nursing Mothers:

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

Adverse Reactions:

Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally
mild and infrequent. Nausea and vomiting are the most common side effects. Dizziness,
headache, and rash (including urticaria) have been reported rarely.

Overdosage:

SIGNS AND SYMPTOMS: Incidence of acute toxicity with guaifenesin is low and over dosage
is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when
guaifenesin was administered by stomach tube in doses up to 5 grams/kg.

TREATMENT: Treatment of the signs and symptoms of overdosage is symptomatic and
supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously.
Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however,
vomiting should not be induced in patients with impaired consciousness. Precautions against
aspiration must be taken, especially in infants and children. Following emesis, any drug
remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water.

Dosage and Administration:

Poly Hist CB is administered orally as follows:

Adults: 1-2 teaspoonfuls every 4-6 hours or as directed by a physician.
Children 6-12 years of age: 1 teaspoonful every 4-6 hours or as directed by a physician.
Children 2-6 years of age: 1/2 teaspoonful every 4-6 hours or as directed by a physician.
Children under 2 years of age: As directed by a physician.


How Supplied:

16 fluid ounce bottles NDC # 50991-781-16 and 15 mL bottles NDC # 50991-781-15

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

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

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

DISPENSE IN TIGHT, LIGHT RESISTANT CONTAINERS WITH CHILD RESISTANT CLOSURES
AS DEFINED IN THE USP/NF.

Manufactured for:
Poly Pharmaceuticals
Mobile, AL 36619

Rx Only

Rev. 11/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

NDC 50991-781-16

Poly Hist CB

Grape Flavor

Sugar Freee      Alcohol Free


Antitussive/Expectorant


Each 5 mL (1 teaspoonful) contains:

Carbetapentane Citrate..... 20 mg
Guaifenesin...................... 75 mg


Distributed by:

Poly Pharmaceuticals
Mobile, AL 36619


Rx Only


16 fl oz (473 mL)



Side Panel:

USUAL DOSAGE: Adults 12 years and older: 1-2 teaspoonfuls every 4-6 hours.
Children 6-12 years of age: 1 teaspoonful every 4-6 hours. Children 2-6 years of age:
1/2 teaspoonful every 4-6 hours. Children under 2 years of age: As directed by a physician.

See package insert for complete prescribing information.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL
CENTER AND SEEK PROFESSIONAL ASSISTANCE 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 controlled room temperature, 59o-86oF (15o-30oC).

Mfg. for:
Poly Pharmaceuticals, Mobile, AL 36619

Mfg. by: Great Southern Laboratories. Houston, TX 77099

Rev. 11/09



POLY HIST  CB
carbetapentane citrate, and guaifenesin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50991-781
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbetapentane Citrate (Carbetapentane) Carbetapentane Citrate 20 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 75 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:50991-781-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/30/2009
Labeler - Poly Pharmaceuticals, Inc. (198449894)
Registrant - Great Southern Laboratories (056139553)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories 056139553 manufacture
Revised: 12/2009
 
Poly Pharmaceuticals, Inc.



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