Phenylephrine Complex Liquid Antihistamine/Nasal Decongestant/Antitussive

PHENYLEPHRINE COMPLEX - phenylephrine hydrochloride, dextromethorphan hydrobromide and brompheniramine maleate liquid 
Breckenridge Pharmaceutical, Inc.

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Phenylephrine Complex Liquid
Antihistamine/Nasal Decongestant/Antitussive

Sugar Free • Alcohol Free • Dye Free

DESCRIPTION

Phenylephrine Complex Liquid is a strawberry-flavored, clear liquid available for oral administration. Each teaspoonful (5 mL) contains:

Phenylephrine HCl7.5 mg
Brompheniramine Maleate4 mg
Dextromethorphan HBr15 mg

INACTIVE INGREDIENTS: Sodium Benzoate, Citric Acid, Saccharin Sodium, Sorbitol Solution, Glycerin, Strawberry Flavor, Purified Water.

Phenylephrine HCl is a nasal decongestant with the chemical name Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-. Its structure is as follows:

Chemical Structure

C9H13NO2•HCl                            M.W. 203.67

Brompheniramine Maleate is an antihistamine with the chemical name: 2-Pyridinepropanamine, γ-(4-bromophenyl)-N,N-dimethyl-, (±)-, (Z)-2-butenedioate (1:1). Its structure is as follows:

Chemical Structure

C16H19BrN2•C4H4O4                  M.W. 435.31

Dextromethorphan Hydrobromide is an antitussive with the chemical name 3-Methoxy-17- methyl-9α, 13α, 14α –morphinan hydrobromide monohydrate. Its structure is as follows:

Chemical Structure

C18H25NO•HBr•H2O                  M.W. 370.32

CLINICAL PHARMACOLOGY

Phenylephrine HCl

Phenylephrine HCl is a sympathomimetic amine which acts predominantly by a direct action on alpha (α) adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta (β) adrenergic receptors of the heart. Clinically, phenylephrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion; and increases nasal airway patency. In therapeutic doses the drug causes little, if any, central nervous system (CNS) stimulation.

Brompheniramine Maleate

Brompheniramine Maleate is an alkylamine-type antihistamine and is among the most potent H1 blockers, and are generally effective in relatively low doses. Although brompheniramine is not so prone as other types of antihistamines to cause drowsiness, a significant proportion of patients do experience this effect. CNS stimulation is more common with alkylamines.

Dextromethorphan

Dextromethorphan acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

INDICATIONS AND USAGE

Phenylephrine Complex Liquid is indicated for temporarily relieving symptoms of upper respiratory tract disorders such as nasal congestion, vasomotor rhinitis and hay fever; as well as for the temporary relief of coughs associated with respiratory tract infections and related conditions such as pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus and/or mucus plugs and congestion. Phenylephrine Complex Liquid is effective in a productive as well as a nonproductive cough, but is of particular value in a dry, nonproductive cough which tends to injure the mucous membrane of the air passages.

CONTRAINDICATIONS

Phenylephrine Complex Liquid is contraindicated in infants and newborns, and in patients with a known hypersensitivity to any of the components. It is also contraindicated in patients with severe hypertension, severe coronary artery disease, hyperthyroidism, and in patients on MAO inhibitor therapy (or for 14 days after stopping MAOI therapy). Patient idiosyncrasy to adrenergic agents may be manifested by insomnia, dizziness, weakness, tremor, or arrhythmias. Patients known to be hypersensitive to other sympathomimetic amines may exhibit cross sensitivity with phenylephrine.

WARNINGS

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

May cause excitability especially in children. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.

Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Discontinue use if adverse reactions occur. Hypertensive crises can occur with concurrent use of phenylephrine and MAO inhibitors (and for 14 days after stopping MAO inhibitor therapy), indomethacin, or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling.

PRECAUTIONS

Information for Patients

Use caution when driving a motor vehicle or operating machinery.

Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

General

Use with caution in patients with diabetes, hypertension, or cardiovascular disease. Before prescribing medication to suppress or modify cough, it is important to ascertain the underlying cause of the cough, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted. Antihistamines have an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hypothyroidism, cardiovascular disease and hypertension.

Drug Interactions

Beta-adrenergic blockers and MAO inhibitors (or for 14 days after stopping MAOI therapy) may potentiate the pressor effect of phenylephrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Pregnancy

Category C

It is not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if the potential benefit justifies potential risk to the fetus.

Nursing Mothers

Small amounts of phenylephrine are excreted in breast milk. Use of this product by nursing mothers is not recommended because of the higher than usual risk for infants from sympathomimetic amines.

Geriatric Use

The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

ADVERSE REACTIONS

The most frequent adverse reactions with this combination product are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness.

Other adverse reactions may include:

Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular: Hypotension, hypertension, cardiac arrhythmias, palpitations.

CNS: Disturbed coordination, tremor, irritability, drowsiness, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.

Urinary System: Urinary frequency, difficult urination.

Gastrointestinal System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System: Tightness of chest and wheezing, shortness of breath.

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

Drug Abuse and Dependence

Central nervous system stimulants have been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable, and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal.

There is no information to indicate that abuse or dependency occurs with guaifenesin or with the combination of guaifenesin, dextromethorphan and phenylephrine.

OVERDOSAGE

This product is comprised of three pharmacologically different components. Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual. A description of symptoms which are likely to appear after ingestion of an excess of the individual components follows:

Signs and Symptoms

Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos and convulsive seizures. Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage and pulmonary edema. It can also cause palpitation, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, hallucinations, and delirium.

Treatment

Treatment of acute overdosage would probably be based upon treating the patient for the symptoms of overdosage of phenylephrine as follows: The treatment of overdosage should provide symptomatic and supportive care. If the amount ingested is considered dangerous or excessive, induce vomiting with ipecac syrup unless the patient is convulsing, comatose, or has lost the gag reflex, in which case perform gastric lavage using a large bore tube. If indicated, follow with activated charcoal and a saline cathartic.

DOSAGE AND ADMINISTRATION

Adults and Children 12 years of age or older: 1 teaspoonful every 6 hours.

Do not exceed 6 teaspoonfuls in a 24-hour period.

Children 6 to 12 years of age: ½ teaspoonful every 6 hours.

Do not exceed 3 teaspoonfuls in a 24-hour period.

This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

HOW SUPPLIED

Phenylephrine Complex Liquid is a clear, strawberry-flavored, sugar-free, alcohol-free, dye-free liquid supplied in 16 fl. oz. bottles, NDC 51991-660-16.

Dispense in a tight, light-resistant container, with a child-resistant closure as defined in the USP/NF.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Warning

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.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx Only

Manufactured by: Tri-Med Laboratories, Inc., Somerset, NJ 08873

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Iss. 8/09

PRINCIPAL DISPLAY PANEL - 473 mL Bottle

Breckenridge
Pharmaceutical, Inc.

NDC 51991-660-16

Phenylephrine
Complex Liquid

Antihistamine/Decongestant/
Antitussive

Description: Each 5 mL (one teaspoonful) for oral
administration contains:

Phenylephrine HCl........................................7.5 mg
Brompheniramine Maleate ..............................4 mg
Dextromethorphan HBr..................................15 mg

INACTIVE INGREDIENTS: Sodium Benzoate,
Citric Acid, Saccharin Sodium, Sorbitol Solution,
Glycerin, Strawberry Flavor, Purified Water.

Rx Only

Net Contents:
16 fl. oz. (One Pint) 473 mL

Principal Display Panel - 473 mL Bottle

PHENYLEPHRINE COMPLEX 
phenylephrine hydrochloride, dextromethorphan hydrobromide and brompheniramine maleate   liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51991-660
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride7.5 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide15 mg  in 5 mL
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
sodium benzoate 
citric acid monohydrate 
saccharin sodium 
sorbitol 
glycerin 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
151991-660-16473 mL In 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/20/2009

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIOperations
Trimed182050567MANUFACTURE
Revised: 11/2009Breckenridge Pharmaceutical, Inc.