DEXTROMETHORPHAN TANNATE, PHENYLEPHRINE TANNATE, DEXCHLORPHENIRAMINE TANNATE
-
dextromethorphan,
phenylephrine and
dexchlorpheniramine suspension
River's Edge Pharmaceuticals, LLC
----------
Dextromethorphan Tannate 30 mg Phenylephrine Tannate 20 mg Dexchlorpheniramine Tannate 2 mgDESCRIPTION
Dextromethorphan Tannate 30 mg/Phenylephrine Tannate 20 mg/Dexchlorpheniramine Tannate 2 mg is a nasal decongestant,antitussive, antihistaminic for oral administration and contains the following amounts of active ingredients in
each 5 mL of suspension:
Dextromethorphan Tannate*....................30 mg
Phenylephrine Tannate*.........................20 mg
Dexchlorpheniramine Tannate*.................2 mg
*Equivalent to 13.5 mg Dextromethorphan base, 6.4 mg Phenylephrine base and 0.9 mg Dexchlorpheniramine base.
Inactive Ingredients: Citric acid, Cotton candy flavor, FDandC Red #40, Glycerin, Propylene glycol, Purified water,
Saccharin sodium, Strawberry flavor, Sodium benzoate and Xanthan gum.
CLINICAL PHARMACOLOGY
Nasal decongestant, antitussive, and antihistaminic actions.Dextromethorphan Tannate:
Dextromethorphan Tannate is a nonnarcotic antitussive with effectiveness equal to codeine. It acts in the medulla oblongata
to elevate the cough threshold. Dextromethorphan Tannate does not produce analgesia or induce tolerance, and has
no potential for addiction. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long
duration. At usual doses, it will not depress respiration nor inhibit ciliary activity. Dextromethorphan Tannate is rapidly
metabolized with trace amounts of the parent compound in blood and urine. About one-half of the administered dose is
excreted in the urine as conjugated metabolites.
Phenylephrine Tannate:
Phenylephrine Tannate is a sympathomimetic that acts predominantly on alpha- receptors and has little action on betareceptors.
Phenylephrine Tannate causes constriction of blood vessels, which shrinks swollen mucous membranes,
reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency. It, therefore, functions as
an oral nasal decongestant while causing minimal central nervous system stimulation.
Dexchlorpheniramine Tannate:
Dexchlorpheniramine Tannate antagonizes the physiological action of histamine by acting as an H1 receptor blocking
agent. In vitro and in vivo assays of the antihistamine potencies of the optically active isomers of Chlorpheniramine
demonstrate that the predominant activity is in the dextro-isomer. The dextro-isomer is approximately two times more
active than the racemic compound.
INDICATIONS AND USAGE
Dextromethorphan Tannate 30 mg/Phenylephrine Tannate 20 mg/Dexchlorpheniramine Tannate 2 mg is indicated forsymptomatic relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or
the common cold.
CONTRAINDICATIONS
Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Do not use in newborn infants, premature infants,
in nursing mothers, in patients with severe hypertension, severe coronary artery disease, ischemic heart disease, or in
those receiving monoamine oxidase (MAO) inhibitors. Antihistamines are contraindicated in patients with narrow-angle
glaucoma, urinary retention, peptic ulcer, and during an asthma attack. Antihistamines should not be used to treat lower
respiratory tract conditions including asthma.
WARNINGS
Do not exceed recommended dosage. Patients with persistent cough such as occur with smoking, asthma, emphysema,
or where cough is accompanied by excessive secretions should not take this product. A persistent cough may be a sign
of a serious condition. If the cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or
persistent headache, consult a doctor. Do not take this product if you have chronic pulmonary disease, shortness of
breath, difficulty in breathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease, or difficulty
in urination due to enlargement of the prostate gland unless directed by a physician. Dexchlorpheniramine
Tannate should be used with extreme caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, or
bladder neck obstruction. Due to its mild atropine-like action, Dexchlorpheniramine Tannate should be used cautiously in
patients with bronchial asthma. Antihistamines may impair mental and physical abilities required for the performance of
potentially hazardous tasks, such as driving a car or operating machinery, and may impair mental alertness in children.
Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness,
dizziness, or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage
may cause hallucinations, convulsions, and death. If nervousness, dizziness, or sleeplessness occurs, discontinue use
and consult a doctor. Administration of Dextromethorphan Tannate may be accompanied by histamine release and
should be used with caution in atopic children.
Hypertensive crises can occur with concurrent use of sympathomimetic amines and monoamine oxidase (MAO)
inhibitors, 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 immediately. Fever should be managed
by means of external cooling.
PRECAUTION
General:
Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of
cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and
that appropriate therapy for the primary disease is provided. Because of its antihistamine component, Dextromethorphan
Tannate 30 mg/Phenylephrine Tannate 20 mg/Dexchlorpheniramine Tannate 2 mg should be used with caution in
patients with a history of bronchial asthma, narrow-angle glaucoma, gastrointestinal obstruction, or urinary bladder neck
obstruction. Because of its sympathomimetic component, Dextromethorphan Tannate 30 mg/Phenylephrine Tannate 20
mg/Dexchlorpheniramine Tannate 2 mg should be used with caution in patients with diabetes, hypertension, heart disease,
or thyroid disease.
Information for Patients:
Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating
dangerous machinery. Patients should be cautioned to get up slowly from a lying or sitting position and to lie down if
nausea occurs.
Drug Interactions:
Prescribe with caution to patients taking any of the following:
Monoamine Oxidase (MAO) inhibitors- Hyperpyrexia, hypotension, and death have been reported coincident with the
co-administration of MAO inhibitors and products containing Dextromethorphan Tannate. In addition, MAO inhibitors
prolong and intensify the anticholinergic (drying) effects of antihistamines. MAO inhibitors may enhance the effect of
Pseudoephedrine and may produce an additive elevation of blood pressure (see WARNINGS).
side effects. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and
veratrum alkaloids.
Central nervous system (CNS) depressants - Antihistamines have additive effects with alcohol and other CNS depressants
(hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or
humans have not been performed.
Pregnancy, Teratogenic Effects-Pregnancy Category C:
Animal reproduction studies have not been conducted with Dextromethorphan Tannate 30 mg/Phenylephrine Tannate 20
mg/Dexchlorpheniramine Tannate 2 mg. It is also not known whether Dextromethorphan Tannate 30 mg/Phenylephrine
Tannate 20 mg/Dexchlorpheniramine Tannate 2 mg can cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity.Dextromethorphan Tannate 30 mg/Phenylephrine Tannate 20 mg/Dexchlorpheniramine
Tannate 2 mg should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in
particular, Dextromethorphan Tannate 30 mg/Phenylephrine Tannate 20 mg/Dexchlorpheniramine Tannate 2 mg is contraindicated
in nursing mothers.
Pediatric Use:
Not recommended for use in patients under 2 years of age.
Geriatric Use:
The elderly (60 years of age or older) are more likely to exhibit adverse reactions. Caution should be taken when prescribing
this drug to the elderly.
ADVERSE REACTIONS
Dexchlorpheniramine Tannate:
Slight to moderate drowsiness may occur and is the most frequent side effect. Other adverse reactions may include:
General - Dryness of mouth, nose, and throat; thickening of bronchial secretions; dizziness, urticaria, drug rash, photosensitivity,
and pruritus.
Cardiovascular System - Hypotension, hypertension, cardiac arrhythmias, palpitations, tachycardia, pallor.
Central Nervous System (CNS) - Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness,
nervousness, convulsions, headache, euphoria, dysphoria, restlessness, insomnia, hallucinations, and CNS depression.
G.U. System - Urinary frequency, difficult urination.
G.I. System - Epigastric discomfort, anorexia, nausea, vomiting, diarrhea or constipation.
Respiratory System - Respiratory difficulty, tightness of chest and wheezing, shortness of breath.
Hematologic System - Hemolytic anemia, thrombocytopenia, agranulocytosis.
OVERDOSAGE
Signs and Symptoms:
May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children
may lead to convulsions and death. Atropine-like signs and symptoms may be prominent. Overdosage of Phenylephrine
Tannate may be associated with CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias. Dextromethorphan
Tannate in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos and convulsive seizures.
Anticholinergic effects may also occur.
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 0.005 mg/kg intravenously may be of value in reversing CNS depression
that may occur from an overdose of Dextromethorphan Tannate. CNS stimulants may counter CNS depression. Should
CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Stimulants
should not be used. Hypertensive responses and/or tachycardia should be treated appropriately. If hypotension is a problem,
vasopressor agents may be considered. Oxygen, intravenous fluids, and other supportive measures should be
employed as indicated.
DOSAGE AND ADMINISTRATION
Adults and children over 12 years of age: 2 teaspoonfuls (10 mL) every 12 hours.
Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 12 hours.
Children 2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) every 12 hours.
Not recommended for Children under 2 years of age.
*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.
Shake well before dispensing.
Do not exceed 2 doses during a 24-hour period.
HOW SUPPLIED
Dextromethorphan Tannate 30 mg/Phenylephrine Tannate 20 mg/Dexchlorpheniramine Tannate 2 mg is an alcohol-free,
sugar-free, red-colored suspension with a cotton candy, strawberry flavor supplied in one pint (473 mL) bottles, with NDC
68032-307-16.
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 controlled room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
Tamper evident by foil seal under cap. Do not use if seal is broken or missing.
Pharmacist: Shake well before dispensing. Dispense in a tight, light-resistant container as defined in the USP/NF with a
child-resistant closure.
Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
307-11
Iss: 08/08
PACKAGING
NDC 68032-307-16
Dextromethorphan Tannate 30 mg
Phenylephrine Tannate 20 mg
Dexchlorpheniramine Tannate 2 mg
Nasal Decongestant
Antitussive
Antihistamine
Each 5 mL (1 teaspoonful) contains:
Dextromethorphan Tannate* ................ 30 mg
Phenylephrine Tannate* ....................... 20 mg
Dexchlorpheniramine Tannate* .............. 2 mg
*Equivalent to 13.5 mg Dextromethorphan base, 6.4 mg Phenylephrine base and 0.9 mg Dexchlorpheniramine base.
SHAKE WELL
Rx Only
One Pint (473 mL)
DOSAGE AND ADMINISTRATION:*
Adults and children over 12 years of age: 2 teaspoonfuls (10 mL) every 12 hours.
Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 12 hours.
Children 2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) every 12 hours.
Not recommended for Children under 2 years of age.
*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.
Shake well before dispensing.
Do not exceed 2 doses during a
24-hour period.
Store at controlled room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Tamper evident by foil seal under cap. Do not use if seal is broken or missing.
Inactive Ingredients: Citric acid, Cotton candy flavor, FDandC Red #40, Glycerin, Propylene glycol, Purified water, Saccharin sodium, Strawberry flavor, Sodium benzoate and Xanthan gum.
PHARMACIST: Shake well before dispensing. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.
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.
Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Iss. 08/08 307-21
| DEXTROMETHORPHAN TANNATE, PHENYLEPHRINE TANNATE, DEXCHLORPHENIRAMINE TANNATE
dextromethorphan tannate 30mg, phenylephrine tannate 20mg, dexchlorpheniramine tannate 2mg suspension |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 08/01/2008 | 07/31/2010 | |
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |