DEXTRO PHENYL PYRIL
-
dextromethorphan,
phenylephrine and
pyrilamine liquid
River's Edge Pharmaceuticals, LLC
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Dextromethorphan Tannate 25 mg Phenylephrine Tannate 15.5 mg Pyrilamine Tannate 15.5 mgDESCRIPTION:
Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg is an antihistamine, antitussive, and decongestant suspension for oral administration.Each teaspoonful (5 mL) contains:
Dextromethorphan Tannate* . . . . . . . . . . . . . . . . 25 mg
Phenylephrine Tannate* . . . . . . . . . . . . . . . . . . 15.5 mg
Pyrilamine Tannate* . . . . . . . . . . . . . . . . . . . . . 15.5 mg
*Equivalent to 11.25 mg Dextromethorphan base, 4.96 mg Phenylephrine base and 6.975 mg Pyrilamine base.
Inactive Ingredients: Cherry flavor, Citric acid, FDandC Red #40, Glycerin, Magnasweet, Saccharin sodium, Sodium benzoate, Purified water and Xanthan gum.
CLINICAL PHARMACOLOGY:
Antihistaminic, Antitussive, and Decongestant 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.
Phenylephrine Tannate: Phenylephrine Tannate is an oral sympathomimetic amine that acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine. Phenylephrine Tannate has less pressor effect in normotensive adults. Serum half-life for Phenylephrine Tannate is 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. About one-half of the administered doses is excreted in the urine.
Pyrilamine Tannate: Pyrilamine Tannate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Pyrilamine Tannate also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilatation, increased vascular permeability, increased mucus secretion) of nasal tissue. Pyrilamine Tannate is well absorbed from the gastrointestinal tract, with peak plasma concentration after a single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.
INDICATIONS AND USAGE:
Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg is indicated for symptomatic 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:
May cause excitability especially in children. May cause nervousness and insomnia in some individuals. At doses higher than the recommended dose nervousness, dizziness, or sleeplessness may occur. Especially in infants and small children, overdosage with products containing antihistamines may cause hallucinations, convulsions and death. Do not give this product to children who have a chronic pulmonary disease, breathing problems such as chronic bronchitis, glaucoma, or those who are taking sedatives or tranquilizers without first consulting with a doctor. Do not give this product for persistent or chronic cough such as occurs with asthma 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 the cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. Administration of Dextromethorphan Tannate may be accompanied by histamine release and should be used with caution in atopic children. Do not exceed the recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.PRECAUTION:
General: Because Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg contains an antihistamine, it should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Due to its sympathomimetic component, Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.
Information for Patients (or Parents): Patients (or parents) should be warned about engaging in activities requiring mental alertness.
Drug Interactions: Do not use this medication in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs used for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAO inhibitor drug. Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing Dextromethorphan Tannate. MAO inhibitor drugs prolong and intensify the anticholinergic effects of antihistamines. MAOI drugs may enhance the effect of Phenylephrine Tannate.
Sympathomimetic agents may reduce the effects of antihypertensive drugs. Antihistamines have additive effects with alcohol and other CNS (Central Nervous System) depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed to assess the carcinogenic and mutagenic potential of Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg or its effect on fertility.
Pregnancy, Teratogenic Effects – Pregnancy Category C: Animal reproduction studies have not been performed with Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg. It is also not known if it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg should be given to a pregnant woman only if clearly needed. Reproduction studies of Pyrilamine Tannate in rats and mice at doses up to 16 times the maximum human dose have revealed no evidence of impaired fertility or harm to the fetus.
Nursing Mothers: Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg is contraindicated in nursing mothers.
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:
The most frequent adverse reactions to Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg include: sedation; dryness of mouth, nose, and throat; thickening of bronchial secretions; dizziness.Other adverse reactions may include:
Dermatologic – urticaria, drug rash, photosensitivity, pruritis.
Cardiovascular System – hypotension, hypertension, cardiac arrhythmias, palpitation.
Central Nervous System (CNS) – disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, dysphoria.
G.U. System – urinary frequency, difficult urination.
G.I. System – epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.
Respiratory System – tightness of chest and wheezing, shortness of breath.
Hematologic System – hemolytic anemia, thrombocytopenia, agranulocytosis.
OVERDOSAGE:
Signs and Symptoms: Central nervous system effects from overdosage of Pyrilamine Tannate may vary from depression to stimulation, especially in children. Anticholinergic effects may also occur. Dextromethorphan Tannate in toxic doses will cause drowsiness, alaxia, nystagmus, opisthotonos, and convulsive seizures. Overdosage of Phenylephrine Tannate may result in CNS stimulation, tachycardia, hypertension and cardiac arrhythmias: signs of CNS depression may occasionally be seen.Toxic Doses: Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2 1/2 year old child survived a dose of 300 – 900 mg of Pyrilamine Tannate. The toxic dose of Phenylephrine Tannate should be less than that of ephedrine, which is estimated to be 50 mg/kg. A 2 1/2 year old child survived the ingestion of 21 mg/kg of Dextromethorphan Tannate exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13-17 mg/kg.
Treatment: Include 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, but in some cases tracheotomy may be needed prior to lavage. For CNS hyperactivity or convulsive seizures, 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 used as indicated. Naloxone hydrochloride 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.
DOSAGE AND ADMINISTRATION:
Adults and children 12 years of age and over: 1 to 2 teaspoonfuls (5-10 mL) every 12 hours;
Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 12 hours;
2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) every 12 hours;
2 years of age: Consult a physician.
DO NOT EXCEED 2 DOSES DURING A 24-HOUR PERIOD.
HOW SUPPLIED:
Dextromethorphan Tannate 25 mg, Phenylephrine Tannate 15.5 mg, Pyrilamine Tannate 15.5 mg is a red-colored, cherryflavored, sugar-free, and alcohol-free liquid supplied in one pint (473 mL) bottles with NDC 68032-327-16.WARNING: KEEP THIS AND ALL MEDICATION 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 15°- 30°C (59°- 86°F).
Dispense in a tight, light-resistant container as defined in the USP.
Shake Well.
Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
327-11 Iss. 08/08
PACKAGING:
NDC 68032-327-16Dextromethorphan Tannate 25 mg
Phenylephrine Tannate 15.5 mg
Pyrilamine Tannate 15.5 mg
SHAKE WELL
Antitussive - Decongestant - Antihistamine
Each teaspoonful (5 mL) contains:
Dextromethorphan Tannate* . . . . . . . . . . . . . . . . 25 mg
Phenylephrine Tannate* . . . . . . . . . . . . . . . . . . 15.5 mg
Pyrilamine Tannate* . . . . . . . . . . . . . . . . . . . . . 15.5 mg
*Equivalent to 11.25 mg Dextromethorphan base, 4.96 mg Phenylephrine base and 6.975 mg Pyrilamine base.
Alcohol and Sugar Free
Rx Only
One Pint (473 mL)
DOSAGE AND ADMINISTRATION:
Adults and children 12 years of age and over: 1 to 2 teaspoonfuls (5-10 mL) every 12 hours;
Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 12 hours;
2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) every 12 hours;
2 years of age: Consult a physician.
DO NOT EXCEED 2 DOSES DURING A 24-HOUR PERIOD.
For full prescribing information, see attached product literature.
Inactive Ingredients: Cherry flavor, Citric acid, FDandC Red #40, Glycerin, Magnasweet, Saccharin sodium, Sodium benzoate, Purified water and Xanthan gum.
Tamper-evident seal is under cap. Do not use if there is evidence of tampering.
STORAGE: Store at controlled room temperature 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F).
PHARMACIST: Preserve and dispense in a tight, light-resistant package with a child-resistant closure as defined in the USP/NF.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:
River's Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Iss. 08/08 327-16
| DEXTRO PHENYL PYRIL
dextromethorphan, phenylephrine, pyrilamine liquid |
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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) |