Poly Hist CB

carbetapentane citrate and guaifenesin

Dosage Form: liquid
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 NDC Product Code (Source) 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

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 50991-781-16 473 mL In 1 BOTTLE None

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: 12/2009Poly Pharmaceuticals, Inc.

More Poly Hist CB resources

• Poly Hist CB Side Effects (in more detail)
• Poly Hist CB Dosage
• Poly Hist CB Use in Pregnancy & Breastfeeding
• Poly Hist CB Drug Interactions
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