Professional Labeling Information and Directions for Use These products labeled for sale on prescription only.
Guaifenesin (glyceryl guaiacolate) has the chemical name 3-(2-methoxyphenoxy)-1,2-propanediol. Its molecular formula is C 10 H 14 O 4 with a molecular weight of 198.21. It is a white or slightly gray crystalline substance with a slightly bitter aromatic taste. One gram dissolves in 20 mL water at 25°C; it is freely soluble in ethanol. Guaifenesin is readily absorbed from the GI tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is (beta)-(2-methoxyphenoxy) lactic acid.
ORGANIDIN® NR* (*Newly Reformulated) (guaifenesin) is an expectorant available for oral administration as:
Tablets -- each containing 200 mg guaifenesin, USP.
Other ingredients: Corn starch, croscarmellose sodium, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose.
Liquid -- each teaspoonful (5 mL) containing 100 mg guaifenesin, USP.
Other ingredients: Caramel, citric acid, flavor (raspberry), glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.
TUSSI-ORGANIDIN® NR* (*Newly Reformulated) and TUSSI-ORGANIDIN® DM NR* (*Newly Reformulated) are antitussive-expectorant combinations available for oral administration as liquids.
TUSSI-ORGANIDIN® NR* (*Newly Reformulated) is a clear red liquid with a raspberry flavor. Each teaspoonful (5 mL) contains guaifenesin, USP 100 mg and codeine phosphate, USP 10 mg.
Other ingredients: Citric acid, FD&C Red No. 40, flavor (artificial), glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.
TUSSI-ORGANIDIN® DM NR* (*Newly Reformulated) Liquid is a clear yellow liquid with a raspberry flavor. Each teaspoonful (5 mL) contains guaifenesin, USP 100 mg and dextromethorphan hydrobromide, USP 10 mg.
Other ingredients: Citric acid, D&C Yellow No. 10, FD&C Red No. 40, flavor (artificial), glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.
ORGANIDIN® NR* (*Newly Reformulated) (guaifenesin) is an expectorant, the action of which promotes or facilitates the removal of secretions from the respiratory tract. By increasing sputum volume and making sputum less viscous, guaifenesin facilitates expectoration of retained secretions.
TUSSI-ORGANIDIN® NR* (*Newly Reformulated) combines the expectorant, guaifenesin, and the cough suppressant, codeine. Codeine is a centrally acting antitussive agent.
TUSSI-ORGANIDIN® DM NR* (*Newly Reformulated) combines the expectorant, guaifenesin, and the cough suppressant, dextromethorphan hydrobromide. Dextromethorphan is a synthetic nonopioid cough suppressant, the dextro isomer of the codeine analogue of levorphanol. Dextromethorphan acts centrally to elevate the threshold for coughing but does not have addictive, analgesic or sedative actions and does not produce respiratory depression with usual doses.
ORGANIDIN® NR* (*Newly Reformulated): Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes and make coughs more productive. Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis.
TUSSI-ORGANIDIN® NR* (*Newly Reformulated) and TUSSI-ORGANIDIN® DM NR* (*Newly Reformulated): Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Calms the cough control center and relieves coughing.
Hypersensitivity to any of the ingredients.
The use of dextromethorphan-containing products are contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs).
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.
Teratogenic Effects--Pregnancy Category C: Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, these products should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards.
Nonteratogenic Effects: Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life.
Labor and Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required.
Nursing Mothers: It is not known whether guaifenesin or dextromethorphan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these products are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
TUSSI-ORGANIDIN® NR* (*Newly Reformulated): Because the hepatic enzyme system, which acts to conjugate codeine to an inactive glucuronide (an important inactivation pathway), is not fully developed in infants less than 6 months of age, the use of codeine is contraindicated in nursing mothers.
Laboratory Test Interactions: Guaifenesin or its metabolites may cause color interference with the VMA (vanillylmandelic acid) test for catechols. It may also falsely elevate the level of urinary 5-HIAA (5-hydroxyindoleacetic acid) in certain serotonin metabolite chemical tests because of color interference.
Information for Patients: TUSSI-ORGANIDIN® NR* (*Newly Reformulated): Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.
TUSSI-ORGANIDIN® DM NR* (*Newly Reformulated):Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson' disease), or for 2 weeks after stopping the MAOI drug. If patients are uncertain whether a prescription drug contains an MAOI, they should be instructed to consult a health professional before taking such a product.
Drug Interactions: TUSSI-ORGANIDIN® NR* (*Newly Reformulated): The use of codeine may result in additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics or other drugs that produce CNS depression.
TUSSI-ORGANIDIN® DM NR* (*Newly Reformulated):Serious toxicity may result if dextromethorphan is coadministered with monoamine oxidase inhibitors (MAOIs). The use of dextromethorphan hydrobromide may result in additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics or other drugs that produce CNS depression.
Guaifenesin is well tolerated and has a wide margin of safety. Side effects have been generally mild and infrequent. Nausea and vomiting are the side effects that occur most commonly. Dizziness, headache, and rash (including urticaria) have been reported rarely.
Codeine [TUSSI-ORGANIDIN® NR* (*Newly Reformulated)]: Nausea, vomiting, constipation, drowsiness, and miosis have been reported. Higher doses may induce euphoria, light-headedness, dizziness, drowsiness and depression of respiration. Pruritus and skin rashes have been rare.
Dextromethorphan [TUSSI-ORGANIDIN® DM NR* (*Newly Reformulated)]: Rare drowsiness or mild gastrointestinal disturbances are the only side effects associated with dextromethorphan in clinical use. [ see also Drug Interactions ]
TUSSI-ORGANIDIN® NR* (*Newly Reformulated) Liquid:
Controlled Substance--Schedule V.
Dependence--Codeine may be habit-forming.
In massive overdosage the stomach should be emptied (emesis and/or gastric lavage) and further absorption prevented. Treatment is symptomatic and supportive.
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 tube in doses up to 5 grams/kg.
Severe intoxication with codeine may result in dyspnea, vertigo, double vision, delusions, hallucinations, speech disturbances, excitement, restlessness, delirium, constricted pupils, respiratory depression (slow and shallow breathing), Cheyne-Stokes respiration, circulatory collapse, stupor and coma.
Treatment of overdosage consists primarily of support of vital functions, especially management of codeine-induced respiratory depression. The narcotic antagonist naloxone is a specific antidote for respiratory depression that may result from overdose or unusual sensitivity from narcotics.
Overdosage with dextromethorphan may produce excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single 300 mg dose of dextromethorphan has been reported.
ORGANIDIN® NR* (*Newly Reformulated) (guaifenesin)
Tablets -- Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.
Liquid -- Adults and children 12 years of age and older: Two to four teaspoonfuls (200 mg to 400 mg) every four hours, not to exceed 2400 mg (24 teaspoonfuls) in 24 hours.
Children 6 years to under 12 years of age: One to two teaspoonfuls (100 mg to 200 mg) every four hours, not to exceed 1200 mg (12 teaspoonfuls) in 24 hours.
Children 2 years to under 6 years of age: 1/2 to 1 teaspoonful (50 mg to 100 mg) every four hours, not to exceed 600 mg (6 teaspoonfuls) in 24 hours.
Children 6 mo. to under 2 years of age: A common dosage is 1/4 to 1/2 teaspoonful (25 mg to 50 mg) every four hours, not to exceed 300 mg (3 teaspoonfuls) in 24 hours. Individualized dosage should be determined by evaluation of patient.
TUSSI-ORGANIDIN® NR* (*Newly Reformulated) Liquid
Adults and children 12 years of age and older: 2 teaspoonfuls (10 mL) every four hours, not to exceed 12 teaspoonfuls (60 mL) in 24 hours.
Children 6 years to under 12 years of age: 1 teaspoonful (5 mL) every four hours, not to exceed 6 teaspoonfuls (30 mL) in a 24 hour period.
Children 2 to under 6 years of age: Oral dosage is based on 1 mg/kg/day of codeine administered in four equal divided doses.
The average body weight for each age group may also be used to determine codeine dosage as follows:
For children 2 years of age (average body weight 12 kg): The oral dosage is 1.5 mL (3 mg codeine + 30 mg guaifenesin) TUSSI-ORGANIDIN® NR* (*Newly Reformulated) Liquid every 4-6 hr, not to exceed 6 mL (12 mg codeine + 120 mg guaifenesin) in a 24 hr period.
For children 3 years of age (average 14 kg): 1.75 mL (3.5 mg codeine + 35 mg guaifenesin) every 4-6 hours, not to exceed 7 mL (14 mg codeine + 140 mg guaifenesin) in 24 hours.
For children 4 years of age (average 16 kg): 2 mL (4 mg codeine + 40 mg guaifenesin) every 4-6 hours, not to exceed 8 mL (16 mg codeine + 160 mg guaifenesin) in 24 hours.
For children 5 years of age (average 18 kg): 2.25 mL (4.5 mg codeine + 45 mg guaifenesin) every 4-6 hours, not to exceed 9 mL (18 mg codeine + 180 mg guaifenesin) in 24 hours.
Patients should be instructed to obtain and use a dispensing device (such as a dropper calibrated for age or weight) to administer the drug to a child, to use extreme care in measuring dosage, and not to exceed the recommended daily dosage.
CODEINE IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER 2 YEARS OF AGE.
Children under 2 years of age may be more susceptible to the respiratory depressant effects of codeine, including respiratory arrest, coma and death.
TUSSI-ORGANIDIN® DM NR* (*Newly Reformulated) Liquid
Adults and children 12 years of age and older: 2 teaspoonfuls (10 mg) every four hours not to exceed 12 teaspoonfuls (60 mL) in 24 hours.
Children 6 years to under 12 years of age: 1 teaspoonful (5 mL) every four hours not to exceed 6 teaspoonfuls (30 mL) in 24 hours.
Children 2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) every four hours not to exceed 3 teaspoonfuls (15 mL) in 24 hours.
Children 6 mo. to under 2 years of age: A common dosage is 1/8 teaspoonful to 1/4 teaspoonful (0.6 mL to 1.25 mL) every 4 hours or 1/2 teaspoonful (2.5 mL) every 6-8 hours, not to exceed 1.5 teaspoonfuls (7.5 mL) in 24 hours. Individualized dosage should be determined by evaluation of patient.
PATIENTS SHOULD BE ADVISED TO KEEP THESE AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.
ORGANIDIN® NR* (*Newly Reformulated) (guaifenesin)
Tablets -- Each round, scored, rose-colored tablet contains 200 mg guaifenesin USP--available in bottles of 100 (NDC 0037-4312-01)
Liquid -- 100 mg guaifenesin per teaspoonful (5 mL)--available as a clear amber liquid in bottles of 1 pint (NDC 0037-4214-10)
TUSSI-ORGANIDIN® NR* (*Newly Reformulated) Liquid -- Guaifenesin 100 mg and codeine phosphate 10 mg per teaspoonful (5 mL) of clear red liquid in bottles of one pint (NDC 0037-4814-10) and 4 fl oz (NDC 0037-4814-01) labeled TUSSI-ORGANIDIN®-S # NR*
TUSSI-ORGANIDIN® DM NR* (*Newly Reformulated) Liquid -- Guaifenesin 100 mg and dextromethorphan hydrobromide 10 mg per teaspoonful (5 mL) of clear yellow liquid in bottles of one pint (NDC 0037-4714-10) and 4 fl oz (NDC 0037-4714-01) labeled TUSSI-ORGANIDIN® DM-S # NR*
# TUSSI-ORGANIDIN®-S NR* and TUSSI-ORGANIDIN® DM-S NR* are TUSSI-ORGANIDIN® NR* and TUSSI-ORGANIDIN® DM NR* Liquids, respectively, either in 4 fl oz unit of use containers with a 10 mL graduated oral syringe and fitment or in 30 mL sample containers.
STORAGE Store at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed.
WALLACE LABORATORIES
Division of Carter-Wallace, Inc.
Cranbury, NJ 08512
IN-046J2-04 Rev. 1/98
|
|
|
|
|
|