Mintuss DR Syrup

Generic Name: dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate
Dosage Form: syrup

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MINTUSS™ DR
SYRUP

Rx Only

Mintuss DR Syrup Description

Mintuss™ DR Syrup is an alcohol-free, sugar-free red syrup with strawberry flavor.

Each teaspoonful (5 mL) contains:
Dextromethorphan hydrobromide 15 mg
Phenylephrine hydrochloride 6 mg
Chlorpheniramine maleate 2 mg

Antitussive/Nasal Decongestant/Antihistaminic syrup for oral administration.

Inactive ingredients

Sodium Benzoate, Citric Acid, Sorbitol Solution, Glycerin, D&C Red #33, FD&C Red #40, Strawberry Flavor and Purified Water.

Phenylephrine Hydrochloride is an orally effective nasal decongestant having the chemical name Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-. Its structure is as follows:

C9H13NO2•HCl           203.67

Chlorpheniramine Maleate is an antihistaminic having the chemical name 2-Pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1). Its structure is as follows:

C16H19CIN2•C4H4O4           390.86

Dextromethorphan Hydrobromide is an antitussive having the chemical name Morphinan, 3-methoxy-17-methyl-, (9α,13α,14α)-, hydrobromide, monohydrate. Its structure is as follows:

C18H25NO • HBr • H2O           370.32

Mintuss DR Syrup - Clinical Pharmacology

Dextromethorphan hydrobromide 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.

Phenylephrine hydrochloride is an α-adrenergic receptor agonist (sympathomimetic) which produces vasoconstriction by stimulating α-receptors within the mucosa of the respiratory tract. Clinically, phenylephrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency.

Chlorpheniramine maleate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. Chlorpheniramine maleate is a member of the alkylamine class of antihistamines which are among the least sedating antihistamines.

INDICATIONS

Mintuss™ DR Syrup is indicated for the temporary relief of coughs and upper respiratory relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Contraindications

Hypersensitivity to any of the ingredients. Because of the drying effect on lower respiratory secretions, Mintuss™ DR Syrup is not recommended in the treatment of bronchial asthma. The product is also contraindicated in patients with severe hypertension, severe coronary artery disease, narrow-angle glaucoma, urinary retention, peptic ulcer, and in patients on MAO inhibitor therapy (or for 14 days after stopping MAOI therapy).

Warnings

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

Hypertensive crisis can occur with concurrent use of phenylephrine and monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy), indomethacin or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued, and therapy to lower blood pressure should be instituted immediately. Fever should be managed by external cooling.

Antihistamines may produce drowsiness or excitation, particularly in children and elderly patients. Do no exceed recommended dosage. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Precautions

General

Because of its antihistamine component, Mintuss™ DR Syrup should be used with caution in patients with a history of bronchial asthma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Mintuss™ DR Syrup should be used judiciously and sparingly in patients with hypertension, diabetes, heart disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

Information for Patients

Antihistamines may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Patients should be cautioned accordingly.

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

Drug Interactions

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.) When such combined therapy is contemplated, the dose of one or both agents should be reduced. The use of phenylephrine with other sympathomimetic amines and MAO inhibitors (or for 14 days after stopping MAOI therapy) may produce an additive elevation of blood pressure. MAO inhibitors (or for 14 days after stopping MAOI therapy) may prolong the anticholinergic effects of antihistamines (See WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Mintuss™ DR Syrup to assess the carcinogenic and mutagenic potential, or the affect on fertility have not been performed.

Usage in Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Mintuss™ DR Syrup. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. It should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Mintuss ™ DR Syrup is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from this product, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in the pediatric population, under 6, have not been established.

Adverse Reactions

The most frequent adverse reactions to Mintuss™ DR Syrup include sedation, dryness of mouth, nose and throat, thickening of bronchial secretions, and dizziness. Other adverse reactions may include:

Dermatologic: Urticaria, drug rash, photosensitivity,and pruritus.

Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias.

Central Nervous System: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.

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

Genitourinary System: Urinary frequency, difficult urination.

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

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

OVERDOSAGE AND TREATMENT OF OVERDOSAGE

Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures. Symptoms of overdosage with phenylephrine include hypertension, headache, convulsions, cerebral hemorrhage, and vomiting. Effects of antihistamine overdosage may vary from central nervous system depression (sedation, apnea diminished mental alertness, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors, or convulsions) to death.

Treatment

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances, tracheotomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdosage of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

Mintuss DR Syrup Dosage and Administration

Adults and children over 12 years

2 teaspoonfuls (10 mL) every 6 hours. Children 6 to 12 years: 1 teaspoonful (5mL) every 6 hours. Do not exceed 4 doses during a 24-hour period. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

How is Mintuss DR Syrup Supplied

Mintuss ™ DR Syrup is an alcohol-free, sugar-free red syrup with a strawberry flavor supplied in bottles of 16 fl oz, NDC 51991-286-16.

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.

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

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

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

Manufactured by: Tri-Med Laboratories, Inc., Somerset, NJ 08873
Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

ISS. 11/02
Rev. 4/08

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-286-16

Mintuss™ DR
Syrup

ACTIVE INGREDIENTS:
Each teaspoonful (5 mL) contains:
Dextromethorphan HBr 15 mg
Phenylephrine HCl 6 mg
Chlorpheniramine Maleate 2 mg

INACTIVE INGREDIENTS: Sodium
Benzoate, Citric Acid, Sorbitol Solution,
Glycerin, D&C Red #33, FD&C Red #40,
Strawberry Flavor and Purified Water.

  • Sugar Free
  • Alcohol Free

Rx Only

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

MINTUSS DR 
dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-286
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 6 mg  in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 2 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Benzoate  
Citric Acid Monohydrate  
Sorbitol  
Glycerin  
D&C Red No. 33  
FD&C Red No. 40  
Water  
Product Characteristics
Color RED Score     
Shape Size
Flavor STRAWBERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-286-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/01/2002 09/30/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Trimed 182050567 MANUFACTURE
Revised: 10/2010
 
Breckenridge Pharmaceutical, Inc.

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