Terra-Cortil may be available in the countries listed below.
Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Terra-Cortil in the following countries:
International Drug Name Search
Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL Liquid is indicated for the temporary relief of symptoms of upper respiratory tract disorders such as nasal congestion, sinusitis, vasomotor rhinitis and hay fever; as well as for the temporary relief of coughs associated with respiratory tract infections and associated conditions such as sinusitis, pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus and/or mucus plugs and congestion. Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL 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.
Adults and Children 12 years of age and older: 1 teaspoonful every 4 to 6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.
Children 6 to 12 years of age: 1/2 teaspoonful every 4 to 6 hours, not to exceed 3 teaspoonfuls in a 24 hour period.
Not recommended for children under 6 years of age.
*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.
Oral solution, brompheniramine maleate 4 mg, phenylephrine hydrochloride 7.5 mg, and dextromethorphan hydrobromide 15 mg/5 mL
Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL Liquid is contraindicated in patients with a known hypersensitivity to any of the components. Patients known to be hypersensitive to other sympathomimetic amines may exhibit cross sensitivity with phenylephrine. It is also contraindicated in infants and newborns, patients with severe hypertension, severe coronary artery disease, hyperthyroidism, and in patients on MAO inhibitor therapy. Patient idiosyncrasy to adrenergic agents may be manifested by insomnia, dizziness, weakness, tremor, or arrhythmias.
Do not exceed recommended dosage. Discontinue use if adverse reactions occur.
5.1 General
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.
5.2 Special Risk Patients
Use with caution in patients with diabetes, hypertension, or cardiovascular disease.
Hypertensive crises can occur with concurrent use of 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.
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.
Sympathomimetics may produce central nervous system stimulation with convulsions or cardio-vascular collapse with accompanying hypotension. Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy.
Side effects may include drowsiness, dizziness, nervousness, insomnia, headache, palpitation, and dysuria.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Beta-adrenergic blockers and MAO inhibitors 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 anesthia may cause serious cardiac arrhythmias.
8.1 Pregnancy
Teratogenic Effects - 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. Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL Liquid should be given to a pregnant woman only if clearly needed.
8.3 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.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients below the age of 6 have not been established.
8.5 Geriatric Use
Elderly patients (60 years of age and older) are more likely to experience adverse reactions to sympathomimetics.
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 talk excessively. 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.
This product is comprised of three pharmacologically different components. Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual.
10.1 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.
10.2 Treatment
Recommended treatment of acute overdosage would likely be based upon treating the patient for the symptoms of overdosage of phenylephrine. 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.
Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL Liquid is an alcohol-free, sugar-free, dye-free, strawberry-flavored, clear liquid.
Each 5 mL (one teaspoonful) for oral administration contains:
Brompheniramine maleate........................................ 4 mg
Phenylephrine hydrochloride ................................. 7.5 mg
Dextromethorphan hydrobromide.............................15 mg
Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL Liquid also contains: glycerin, propylene glycol, sorbitol, citric acid, sodium citrate, sodium saccharin, strawberry flavor, purified water.
Brompheniramine Maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine,у-(4-bromophenyl)-N, N-dimethyl-, (±)-,(Z)-2-butenedioate (1:1), with the following structure:
Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically it is (–)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride with the following chemical structure:
Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. Chemically, it is 3-methoxy-17-9α, 13α, 14α-morphinan hydrobromide monohydrate and has the following structural formula:
12.1 Mechanism of Action
Brompheniramine maleate
Alkylamine-type antihistamines such as brompheniramine maleate are among the most potent H1 blockers and are generally effective in relatively low doses. Although brompheniramine is not as 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.
Phenylephrine HCl
Phenylephrine hydrochloride 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.
Dextromethorphan hydrobromide
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.
16.1 How Supplied
Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL Liquid is an alcohol-free, sugar-free, dye-free, strawberry-flavored, clear liquid supplied in 16 oz. (473 mL) bottles, NDC 68032-456-16.
16.2 Storage and Handling
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 59°-86°F (15°-30°C) [See USP Controlled Room Temperature].
PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
Patients receiving Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL Liquid should be given the following information:
1. Do not exceed the recommended dosage of Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL Liquid.
2. Report adverse experiences occurring during therapy.
3. Brom Mal/Phenyl HCl/ Dex HBr 4/7.5/15 mg/5 mL Liquid may cause drowsiness or excitability.
*Sections or subsections omitted from the full prescribing information are not listed.
Manufactured for:
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 01/10 456-10
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 02/10/2010 | ||
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |
Somatuline Depot is a brand name of lanreotide, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Somatuline Depot available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Somatuline Depot. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Myk 1 may be available in the countries listed below.
Sulconazole nitrate (a derivative of Sulconazole) is reported as an ingredient of Myk 1 in the following countries:
International Drug Name Search
Bioclindax may be available in the countries listed below.
Clindamycin is reported as an ingredient of Bioclindax in the following countries:
International Drug Name Search
Epilexter may be available in the countries listed below.
Oxcarbazepine is reported as an ingredient of Epilexter in the following countries:
International Drug Name Search
Vicimex may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Vicimex in the following countries:
International Drug Name Search
Optivermin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Fenbendazole is reported as an ingredient of Optivermin in the following countries:
Praziquantel is reported as an ingredient of Optivermin in the following countries:
International Drug Name Search
Relieving symptoms of sinus congestion, runny nose, sneezing, cough, and throat and airway irritation due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Bromhist-PDX Syrup is an antihistamine, decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing while the cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Bromhist-PDX Syrup. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Bromhist-PDX Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Bromhist-PDX Syrup 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.
Use Bromhist-PDX Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Bromhist-PDX Syrup.
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:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.
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: Bromhist-PDX side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.
Store Bromhist-PDX Syrup at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bromhist-PDX Syrup out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Bromhist-PDX Syrup. 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.
Toprol-XL is a brand name of metoprolol, approved by the FDA in the following formulation(s):
A generic version of Toprol-XL has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Toprol-XL and have been approved by the FDA:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Toprol-XL. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Toprol-XL.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Generic Name: diclofenac transdermal (dye KLOE fen ak)
Brand Names: Flector Patch
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
Diclofenac transdermal skin patch is used to treat pain caused by minor sprains, strains, or bruising.
Diclofenac transdermal may also be used for other purposes not listed in this medication guide.
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have heart disease, congestive heart failure, high blood pressure, a history of heart attack or stroke, a history of stomach ulcer or bleeding, liver or kidney disease, a blood clotting disorder, asthma or polyps in your nose, or if you smoke.
While the risk of absorbing diclofenac transdermal into your bloodstream is low, an NSAID may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.
This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac transdermal, especially in older adults.
While the risk of absorbing diclofenac transdermal into your bloodstream is low, an NSAID can cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.
This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac transdermal, especially in older adults.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medicine:
a history of drug allergies;
a history of heart attack, stroke, or blood clot;
heart disease, congestive heart failure, high blood pressure;
a history of stomach ulcer or bleeding;
a bleeding or blood clotting disorder;
asthma;
polyps in your nose; or
if you smoke.
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Using extra skin patches will not make the medication more effective. Follow the directions on your prescription label.
Apply the skin patch directly to the area of pain. The skin patch can be worn for up to 12 hours and then removed. Apply a new patch at that time if pain continues. Do not wear a skin patch while taking a bath or shower or while swimming.
If the patch falls off, try sticking it back on, or use medical tape to hold it on.
If you use this medication long-term, your blood may need to be tested often. Your blood pressure may also need to be checked. Visit your doctor regularly.
Apply a skin patch as soon as you remember, and wear it for 12 hours before applying a new one. Do not use extra patches to make up the missed dose. Do not wear a diclofenac skin patch for longer than 12 hours.
Avoid taking aspirin, oral (pill form) diclofenac (Cataflam, Voltaren), or other NSAIDs without your doctor's advice. This includes ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.
Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.
chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;
bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
fever, chills, body aches, flu symptoms;
pale or yellowed skin, dark colored urine, confusion;
swelling or rapid weight gain;
urinating less than usual or not at all;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
the first sign of any skin rash, no matter how mild.
Less serious side effects may include:
mild nausea, vomiting;
diarrhea, constipation;
upset stomach, heartburn, gas;
dizziness; or
mild itching, burning, redness, or other skin irritation where the patch was worn.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Keratosis:
3% Gel: Apply amount sufficient to cover each actinic keratosis lesion twice daily and rub in gently for 60 to 90 days. Complete healing of lesions may not be evident for 30 days after discontinuation of therapy.
Usual Adult Dose for Osteoarthritis:
1% Gel:
Apply the gel (4 g) to the affected foot or knee or ankle four times daily and rub in gently. Do not apply more than 16 g daily to any single joint of the lower extremities.
Apply the gel (2 g) to the affected hand or elbow or wrist four times daily and rub in gently. Do not apply more than 8 g daily to any single joint of the upper extremities.
Total dose should not exceed 32 g per day, over all affected joints.
Topical solution 1.5%:
10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread around evenly around front, back, and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution. Wash hands completely after administering product. Wait until the area is completely dry before covering with clothing or applying sunscreen, insect repellent, cosmetics, topical medications, or other substances.
Usual Adult Dose for Pain:
1.3% topical patch:
Acute pain due to minor strains, sprains, and contusions:
Apply one patch to the most painful area twice a day.
Tell your doctor about all other medicines you use, especially:
a blood thinner such as warfarin (Coumadin);
cyclosporine (Gengraf, Neoral, Sandimmune);
lithium (Eskalith, Lithobid);
methotrexate (Rheumatrex, Trexall);
a diuretic (water pill);
steroids (prednisone and others); or
heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.
It is not likely that other drugs you take orally or inject will have an effect on topically applied diclofenac. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
