Sedotussin Plus

Carbetapentane Citrate:

• Poly hist cb
• Clinical pharmacology:
• Indications and usage:
• Contraindications:
• Warnings:
• Precautions:
• Carcinogenesis, mutagenesis, and impairment of fertility:
• Pregnancy:
• Nursing mothers:
• Adverse reactions:
• Overdosage:
• Dosage and administration:
• How supplied:
• Product packaging:
• Sedotussin Plus (Carbetapentane Citrate) reviews

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:

Sedotussin Plus (Carbetapentane Citrate) 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:

Sedotussin Plus (Carbetapentane Citrate) 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, 59^o-86^oF (15^o-30^oC).

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:

Sedotussin Plus (Carbetapentane Citrate) 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, 59^o-86^oF (15^o-30^oC).

Mfg. for: Poly Pharmaceuticals, Mobile, AL 36619

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

Rev. 11/09

Poly Hist CB Packaging Poly Hist CB Packaging

Chlorpheniramine Maleate:

• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? comments?
• Sedotussin Plus (Chlorpheniramine Maleate) reviews

Drug Facts

Active Ingredients (in each 1 mL dropperful)	Purpose
Sedotussin Plus (Chlorpheniramine Maleate) Maleate 2 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product in a child who is

• now taking a prescription monoamine oxidase inhibitor (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if a child has

• a breathing problem such as chronic bronchitis
• glaucoma
• heart disease
• high blood pressure
• thyroid disease
• diabetes mellitus

Ask a doctor before use if a child is taking sedatives or tranquilizers

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• sedatives and tranquilizers may increase drowsiness effect

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• new symptoms occur

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Children 6 to under 12 years of age:	1 mL (1 dropperful) every 4 hours, not to exceed 6 mL in 24 hours or as directed by a doctor
Children 2 to under 6 years of age:	0.5 mL (1/2 dropperful) every 4 hours, not to exceed 3 mL in 24 hours, or as directed by a doctor
Children under 2 years of age:	Consult a doctor

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Applesauce Flavor, Citric Acid, FD&C Blue #1, FD&C Yellow #6, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose

Questions? Comments?

Call 1-800-543-9560

Rev. 05/11

E

NEW

FORMULA

NDC 00485-0096-02

Sedotussin Plus (Chlorpheniramine Maleate)

Pediatric Drops

Antihistamine ▪ Nasal Decongestant

Sugar Free ▪ Alcohol Free ▪ Gluten Free

FOR PROFESSIONAL USE ONLY

Each 1 mL for oral administration

contains:

Sedotussin Plus (Chlorpheniramine Maleate) Maleate

2 mg

Phenylephrine HCl

5 mg

APPLESAUCE FLAVOR

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

2 fl. oz. (60 mL)