Dryphen

Pronunciation: ah-seet-ah-MIN-oh-fen/klor-fen-EER-a-meen/fen-ill-EF-rin
Generic Name: Acetaminophen/Chlorpheniramine/Phenylephrine
Brand Name: Examples include Pyrroxate and Dryphen

Dryphen is used for:

Relieving symptoms of colds, hay fever, and allergies such as headache, sinus pain, nasal and sinus congestion, sneezing, watery eyes, runny nose, fever, and itching of the nose or throat. It may also be used for other conditions as determined by your doctor.

Dryphen is an antihistamine, decongestant, and pain reliever combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion and pain associated with sinus pressure, and dries the nose and chest.

Do NOT use Dryphen if:

• you are allergic to any ingredient in Dryphen


• you are taking sodium oxybate (GHB) or a monoamine oxidase (MAO) inhibitor (eg, phenelzine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dryphen:

Some medical conditions may interact with Dryphen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have breathing problems (eg, emphysema, asthma), heart disease, diabetes, difficulty urinating, an enlarged prostate, glaucoma, high blood pressure, an overactive thyroid, liver or kidney problems, adrenal gland problems (eg, pheochromocytoma), sleep apnea, trouble sleeping, stomach problems, urinary blockage, or viral hepatitis

Some MEDICINES MAY INTERACT with Dryphen. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), droxidopa, isoniazid, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects may be increased


• Blood thinners (eg, warfarin), bromocriptine, furazolidone, MAO inhibitors (eg, phenelzine), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the actions and side effects may be increased


• Certain high blood pressure medicines such as beta-blockers (eg, atenolol) and guanethidine because these medicines may be less effective

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dryphen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dryphen:

Use Dryphen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dryphen may be taken with food if it upsets your stomach.


• If you miss a dose of Dryphen and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dryphen.

Important safety information:

• Dryphen may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Dryphen. Using Dryphen alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Dryphen will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Do not exceed the recommended dose of Dryphen. Doing so will not improve your condition faster and may increase your risk for side effects.


• If your symptoms do not improve within a few days or if they become worse, check with your doctor.


• Dryphen contains acetaminophen. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do not take diet or appetite control medicines while you are taking Dryphen without checking with your doctor.


• If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Dryphen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Dryphen may increase your risk for liver damage.


• If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Dryphen.


• Caution is advised when using Dryphen in the ELDERLY because they may be more sensitive to its effects.


• Use Dryphen with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if Dryphen can cause harm to the fetus. If you become pregnant while taking Dryphen, discuss with your doctor the benefits and risks of using Dryphen during pregnancy. Some of the ingredients in Dryphen are excreted in breast milk. If you are or will be breast-feeding while you are using Dryphen, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Dryphen:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth, nose, or throat; headache; nausea; nervousness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine or pale stools; difficulty urinating; hallucinations; high blood pressure; rapid pulse; severe nervousness; stomach pain; tremors; unusual fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dryphen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sweating; tremors; trouble breathing; unusual drowsiness or dizziness; vomiting.

Proper storage of Dryphen:

Store Dryphen at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dryphen out of the reach of children and away from pets.

General information:

• If you have any questions about Dryphen, please talk with your doctor, pharmacist, or other health care provider.


• Dryphen is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dryphen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dryphen resources

• Dryphen Side Effects (in more detail)
• Dryphen Use in Pregnancy & Breastfeeding
• Dryphen Drug Interactions
• Dryphen Support Group
• 0 Reviews for Dryphen - Add your own review/rating

• Dryphen Concise Consumer Information (Cerner Multum)

Compare Dryphen with other medications

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• Sinus Symptoms

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Bromhist-PDX Syrup

brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride and guaifenesin

Dosage Form: syrup
Bromhist-PDX Syrup

Bromhist-PDX Syrup

NDC 60258-429-16


Rx Only


DESCRIPTION

Bromhist-PDX Syrup is an antihistaminic, antitussive, nasal decongestant, expectorant syrup for oral administration and contains the following amounts of active ingredients in each 5 mL of syrup:


Brompheniramine Maleate...............................................2 mg

Dextromethorphan HBr....................................................5 mg

Phenylephrine HCl..........................................................5 mg

Guaifenesin..................................................................50 mg


Inactive Ingredients:  Propylene Glycol, Glycerin, Sorbitol, Maltitol, Citric Acid, Sodium Citrate, Sodium Saccharin, FD and C Red #40, FD and C Blue #1, Grape Flavor, Purified Water


Brompheniramine Maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine,γ-(4-bromo-phenyl)-N, N-dimethyl-,(±)-,(Z)-2-butenedioate (1:1).

Dextromethorphan hydrobromide is an antitussive having the chemical name, morphinan, 3-methoxy-17methyl-, (9α, 13α, 14α)-, hydrobromide, monohydrate.

Phenylephrine hydrochloride is a mydriatic and a decongestant and occurs as bitter crystals.  The chemical name is: (-)-m-Hydroxy-α-[methylamino)methyl]benzyl alcohol hydrochloride.

Guaifenesin is an expectorant having the chemical name, 1, 2-propanediol, 3-(2-mthoxyphenoxy)-,(±)-.

Bromhist-PDX Syrup - Clinical Pharmacology

Antihistaminic, antitussive, nasal decongestant, and expectorant actions.


Brompheniramine Maleate

Brompheniramine maileate 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.  Brompheniramine also has anticholinergic (drying) and sedative effects.  Among the antihistaminic effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue.


Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after 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.


Dextromethorphan Hydrobromide

Dextromethorphan hydrobromide is a nonnarcotic antitussive with effectiveness equal to codeine.  It acts in the medulla oblongata to elevate the cough treshold.  Dextromethorphan 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 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 Hydrochloride

Phenylephrine hydrochloride is a sympathomimetic that acts predominantly on alpha receptors and has little action on beta receptors.  Phenylephrine causes constriction of blood vessels, which shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal decongestant while causing minimal central nervous system stimulation.


Guaifenesin

Guaifenesin, by increasing respiratory tract fluid, reduces the viscosity of tenacious secretions and acts as an expectorant.  Guafenesin is excreted in the urine mainly as gluconates and sulfonates.

Indications and Usage for Bromhist-PDX Syrup

Bromhist-PDX Syrup 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 patients with severe hypertension, sever 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

Patients with persistent cough such as occurs 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.


Use caution when giving to children or patients with chronic pulmonary disease, shortness of breath, difficulty 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.


Antihistamine 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.


Do not exceed the recommended dosage.  If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.


Administration of dextromethorphan 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.

Precautions

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, Bromhist-PDX Syrup 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, Bromhist-PDX Syrup 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.  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).


Sympathomimetics - Used concurrently, may increase the effects of guaifenesin, thereby increasing the potential for 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.).

Drug/Laboratory Test Interactions

Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect of fertility in animals or humans have not been performed.

Pregnancy, Teratogenic Effects-Pregnancy Category C

Animal reproduction studies have not been conducted with Bromhist-PDX Syrup.  It is also not known whether Bromhist-PDX Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Bromhist-PDX Syrup should be given to a pregnant woman only if clearly needed.


Reproduction studies of brompheniramine maleate 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

Caution should be exercised when Bromhist-PDX is administered to a nursing woman due to the risk of intolerance of antihistamines in small infants generally, and in newborns and premature infants in particular.

Pediatric Use

No recommended for use in patients under 2 years of age.
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 Bromhist-PDX Syrup include sedation; dryness of mouth, nose, and throat; thickening of bronchial secretins; dizziness.  Other adverse reactions may include:


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


Cardiovascular System - Hypotension, hypertension, cardiac arrhythmias, palpitations, tachycardia, pallor.


Central Nervous System (CNS) - Distrubed 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

Overdosage of phenylephrine may be associated with CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias.  Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos and convulsive seizures.  Central nervous system effects from overdosage of bromphenirmine may vary from depression to stimulation, especially in children.  Anticholinergic effects may also occur.


Toxic Doses

The acute toxicity of guaifenesin is low and overdosage is unlikely to produce serious toxic effects.  In laboratory animals no toxicity resulted when guaifenesin was administered by stomach t.b. in doses up to 5 grams/kg.  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 the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13-17 mg/kg.  One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single 300 mg dose of dextromethorphan has been reported.  The toxic dose of phenylephrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.  Another 2 1/2 year old child survived a dose of 300-900 mg of brompheniramine.


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 CNS depression that may occur from an overdose of dextromethorpan.  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.

DOSAGE* AND ADMINISTRATION

Adults and children 12 years of age and over:

2 teaspoonfuls every 4 to 6 hours, not to exceed 12 teaspoonfuls in 24 hours.

Children 6 to under 12 years of age:

1 teaspoonful every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours.

Children 2 to under 6 years of age:

1/2 teaspoonful every 4 to 6 hours; not to exceed 3 teaspoonfuls in 24 hours.

Not recommended for use in children under 2 years of age.

*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.

How is Bromhist-PDX Syrup Supplied

Bromhist-PDX Syrup is an alcohol-free, purple syrup with a grape flavor in 16 fl oz (473 mL) bottles, NDC 60258-429-16.


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.


Rx Only


Store at 20°-25°C(68°-77°F) [see USP Controlled Room Temperature].  Excursions permitted to 15°-30°C(59°-86°F).


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


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


Manufactured for:

Cypress Pharmaceuticals, Inc.

Madison, MS  39110


I236 Rev. 4/10

Product Packaging:

The packaging below represents label currently used:


Principal display panel and side panel for 473 mL label:


NDC 60258-429-16


Bromhist-PDX Syrup


Antihistamine/Antitussive/Nasal Decongestant/Expectorant


Each teaspoonful (5 mL) for oral adminstration contains:

Brompheniramine Maleate.......................................2 mg

Dextromethorphan HBr............................................5 mg

Phenylephrine HCl...................................................5 mg

Guaifenesin...........................................................50 mg


ALCOHOL FREE


Rx Only


Cypress Pharmaceutical, INC.


16 fl oz (473 mL)


DOSAGE* AND ADMINISTRATION:

Adults and children 12 years of age and over:  2 teaspoonfuls every 4 to 6 hours, not to exceed

12 teaspoonfuls in 24 hours.

Children 6 to under 12 years of age:  1 teaspoonful every 4 to 6 hours, not to exceed

6 teaspoonfuls in 24 hours.

Children 2 to under 6 years of age:  1/2 teaspoonful every 4 to 6 hours, not to exceed

3 teaspoonfuls in 24 hours.

Not recommended for use in children under 2 years of age.

*In mild cases or in particularly sensitive patients, less frequent or reduced doses

may be appropriate and adequate.


See attached insert for full prescribing information.


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 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Excursions permitted to 15°-30°C (59°-86°F).


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


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


This package not to be dispensed to the patient.


Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088.


Mfg. for:  Cypress Pharmaceutical, Inc., Madison, MS  39110

L462 Rev 4/10

BROMHIST  PDX brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 60258-429 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate 2 mg  in 5 mL Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 5 mg  in 5 mL Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg  in 5 mL Guaifenesin (Guaifenesin) Guaifenesin 50 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 60258-429-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/28/2006

Labeler - Cypress Pharmaceutical, Inc (790248942)

Revised: 06/2010Cypress Pharmaceutical, Inc

More Bromhist-PDX Syrup resources

• Bromhist-PDX Syrup Side Effects (in more detail)
• Bromhist-PDX Syrup Dosage
• Bromhist-PDX Syrup Use in Pregnancy & Breastfeeding
• Bromhist-PDX Syrup Drug Interactions
• Bromhist-PDX Syrup Support Group
• 0 Reviews for Bromhist-PDX - Add your own review/rating

Compare Bromhist-PDX Syrup with other medications

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