Coftex-DMR Tablets

Cetirizine:

• Active ingredients (in each extended release tablet)
• Purpose
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions?
• Coftex-DMR Tablets (Cetirizine) reviews

Drug Facts

Active ingredients

Coftex-DMR Tablets (Cetirizine) HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal decongestant

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • nasal congestion
• reduces swelling of nasal passages
• temporarily relieves sinus congestion and pressure
• temporarily restores freer breathing through the nose

Warnings

Do not use

• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
• if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• thyroid disease
• diabetes
• glaucoma
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

• do not use more than directed
• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• an allergic reaction to this product occurs. Seek medical help right away.
• you get nervous, dizzy, or sleepless
• symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding:

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• do not break or chew tablet; swallow tablet whole

Other information

• store between 20° to 25°C (68° to 77°F)
• do not use if individual blister unit is open or torn
• see back panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

call 1-800-343-7805

Dextromethorphan:

• Pharmacological action
• Pharmacokinetics
• Why is Coftex-DMR Tablets prescribed?
• Dosage and administration
• Coftex-DMR Tablets (Dextromethorphan) side effects, adverse reactions
• Coftex-DMR Tablets contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Coftex-DMR Tablets drug interactions
• Coftex-DMR Tablets in case of emergency / overdose
• Coftex-DMR Tablets (Dextromethorphan) reviews

Pharmacological action

Coftex-DMR Tablets is an antitussive medication. Inhibiting the excitability of the cough center this medicine suppresses the cough of any origin. Coftex-DMR Tablets (Dextromethorphan) has not addiction effects and it has no analgesic and hypnotic action. Coftex-DMR Tablets (Dextromethorphan) starts to act after 10-30 minutes after oral administration, the duration of therapeutic action: 5-6 hours for adults and 6-9 hours for children. Coftex-DMR Tablets (Dextromethorphan) is an optical isomer of levomethorphan which is similar to morphine. Due to optical isomerism this drug has no opioid effects. Coftex-DMR Tablets (Dextromethorphan) used mainly for replacement of codeine as a cough suppressant. In addition to the cough suppressant this medication is used in medicine for diagnostic purposes and may be useful in various cases - from seizures to heroin addiction treatment, some chronic neurodegenerative diseases. These include amyotrophic lateral sclerosis (ALS) (Charcot's disease), disease of "mad cow and other prion diseases. Coftex-DMR Tablets (Dextromethorphan) has also been used for the treatment of mental retardation, Parkinson's disease, in the treatment of lung and other cancers and to prevent tissue rejection in transplantation because of the (poorly known) effects of sigma ligands on tumor cells and immune system.

Pharmacokinetics

After oral administration Coftex-DMR Tablets (Dextromethorphan) is completely absorbed from the gastrointestinal tract. C_max of Coftex-DMR Tablets (Dextromethorphan) in plasma is reached after 2 h. This medication biotransformes in the liver. Up to 45% of this drug is excreted by kidneys and there was considerable individual variation in rates of excretion of individual metabolites.

Why is Coftex-DMR Tablets prescribed?

Dry cough of different etiology.

Dosage and administration

For adults and children over 12 years Coftex-DMR Tablets prescribed on 15 mg 4 times / day, children aged 6 years - 7.5 mg 4 times / day.

Coftex-DMR Tablets (Dextromethorphan) side effects, adverse reactions

Drowsiness, nausea, dizziness.

Coftex-DMR Tablets contraindications

Bronchial asthma, bronchitis, simultaneous reception of mucolytic.

Using during pregnancy and breastfeeding

During pregnancy and lactation (breastfeeding) Coftex-DMR Tablets (Dextromethorphan) prescribed with caution, only in cases where the expected therapeutic effect for the mother outweighs the potential risk to the fetus or child.

Special instructions

With carefully administered Coftex-DMR Tablets (Dextromethorphan) with impaired liver function.

Coftex-DMR Tablets drug interactions

MAO inhibitors (including furazolidone, procarbazine, selegiline) when administered simultaneous with Coftex-DMR Tablets (Dextromethorphan) may cause adrenergic crisis, collapse, coma, dizziness, agitation, increased blood pressure, hyperpyrexia, intracranial hemorrhage, lethargy, nausea, cramps, tremor. In combination with tricyclic antidepressants (amitriptyline, etc.) Coftex-DMR Tablets (Dextromethorphan) may appeal serotonin syndrome and possible subsequent death. Amiodarone, fluoxetine, quinidine, inhibiting system cytochrome P450, may increase the drug concentration in the blood. Tobacco smoke can lead to increased secretion of glands in the background of inhibition of cough reflex. Some inhibitors of CYP450 (such as quinidine) increase and extended effects of this medicine.

Coftex-DMR Tablets in case of emergency / overdose

Symptoms: excitement, dizziness, respiratory depression, impaired consciousness, decreased blood pressure, tachycardia, muscle hypertonicity, ataxia.

Treatment: mechanical ventilation, symptomatic agents.

Guaifenesin:

• Coftex-DMR Tablets (Guaifenesin) reviews

Indication: Used to assist the expectoration of phlegm from the airways in acute respiratory tract infections.

Coftex-DMR Tablets (Guaifenesin) is an expectorant which increases the output of phlegm (sputum) and bronchial secretions by reducing adhesiveness and surface tension. The increased flow of less viscous secretions promotes ciliary action and changes a dry, unproductive cough to one that is more productive and less frequent. By reducing the viscosity and adhesiveness of secretions, Coftex-DMR Tablets (Guaifenesin) increases the efficacy of the mucociliary mechanism in removing accumulated secretions from the upper and lower airway.

Phenylephrine:

• Drug facts
• Purpose
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? comments?
• Product packaging
• Coftex-DMR Tablets (Phenylephrine) reviews

Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Coftex-DMR Tablets (Phenylephrine) Hydrochloride 10 mg

Purpose

Antihistamine

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

• if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to enlargement of the prostate gland
• heart disease
• high blood pressure
• thyroid disease
• diabetes
  

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery
  

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever
  

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Coftex-DMR Tablets (Phenylephrine) Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD &C Blue #1 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.

Questions? Comments?

Call1-800-882-1041

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355 Rev. 02/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-782-60

Coftex-DMR Tablets (Phenylephrine)

Tablets

Antihistamine - Nasal Decongestant

Each tablet contains:

Dexbrompheniramine Maleate...2 mg

Coftex-DMR Tablets (Phenylephrine) Hydrochloride...10 mg

60 Tablets

Usual

Dosage: See product foldout for full prescribing information.

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

broken or missing.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Store at controlled room temperature between 15°-30°C (59°-86°F).

Manufactured for:

Poly Pharmaceuticals

Quitman, MS 39355

Rev. 02/12

Coftex-DMR Tablets (Phenylephrine) Tablets Packaging Coftex-DMR Tablets (Phenylephrine) Tablets Packaging