{"adverse_reactions":["ADVERSE REACTIONS Antitussives: may include drowsiness, dizziness, nausea or vomiting, constipation, dry mouth, headache, nervousness or restlessness, feeling of well-being, confusion, urinary disturbances, increased sweating, skin rash, hives, itching, swelling of face, flushing, weakness, visual disturbances, change in heart rate, difficulty breathing, loss of appetite, or general feeling of illness or discomfort. Possible allergic reaction to material if inhaled, ingested, or in contact with skin. Sympathomimetic Amines: Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias and cardiovascular collapse with hypotension. Antihistamines: Patients sensitive to antihistamines may experience mild sedation. Possible side effects of antihistamines are drowsiness, restlessness, dizziness, weakness, dry mouth, anorexia, nausea, vomiting, headache, nervousness, blurring of vision, polyuria, heartburn, dysuria and very rarely, dermatitis. Other adverse reactions include: Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes. Gastrointestinal System: The antiemetic phenothiazines are useful in suppressing the nausea and vomiting which may occur (see above); however, some phenothiazine derivatives seem to be antianalgesic and to increase the amount of narcotic required to produce pain relief, while other phenothiazines reduce the amount of narcotic required to produce a given level of analgesia. Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported. Respiratory Depression: Codeine may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Codeine also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. Apply other supportive measures when indicated."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Codeine Phosphate Codeine is a centrally acting analgesic and antitussive which is well absorbed orally. Following absorption, codeine is metabolized by the liver and metabolic products are excreted in the urine. Phenylephrine Hydrochloride Phenylephrine 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. Following oral administration, constriction of blood vessels in the nasal mucosa may relieve nasal congestion. In therapeutic doses the drug causes little, if any, central nervous system stimulation. Diphenhydramine Hydrochloride Diphenhydramine hydrochloride is an ethanolamine antihistamine with anticholinergic (drying) and sedative effects. It competitively antagonizes histamine at H 1 , histamine receptors in the central nervous system and in the periphery. Histaminergic effects (increased capillary permeability and dilatation, edema formation, \"flare\" and \"itch\" response, vasoconstriction and vasodilatation, and gastrointestinal and smooth-muscle constriction) are especially blocked by diphenhydramine. H 1 antihistamines competitively antagonize histamine binding and do not block its release."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to phenylephrine, codeine, sympathomimetic amines, diphenhydramine, or other antihistamines of similar chemical structure. Because of its drying effect on lower respiratory secretions, ENDAL® CD is not recommended in the treatment of bronchial asthma. Also contraindicated in patients with severe hypertension or severe coronary artery disease, in patients on MAO inhibitor therapy, in patients with narrow-angle glaucoma, urinary retention, or peptic ulcer, during an asthmatic attack, in nursing mothers, and in premature or newborn infants."],"description":["ENDAL CD SYRUP Antitussive/Decongestant Antihistamine Rx Only CV DESCRIPTION A cherry-flavored, sugar-free, alcohol-free, dye-free, clear syrup for oral administration. Each 5 mL (teaspoonful) contains: Codeine phosphate...................... 7.5 mg (WARNING: May be habit forming) Phenylephrine hydrochloride......... 7.5 mg Diphenhydramine hydrochloride..... 10 mg The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The chemical name is: Morphinan-6-ol,7, 8-didehydroxy-4,5-epoxy-3-methoxy-17-methyl-, (5α, 6α)-,phosphate (1:1) (salt), hemihydrate. Its structure is as follows: 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. Its structure is as follows: Diphenhydramine hydrochloride is an antihistaminic. The chemical name is 2-(diphenylmethoxy)-N, N- dimethylethylamine hydrochloride. Its structure is as follows: Inactive ingredients: Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, Cherry Flavor, Purified Water. Codeine Phosphate Chemical Structure Phenylephrine Hydrochloride Chemical Structure Diphenhydramine Hydrochloride Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and children 12 years of age and over - 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 8 teaspoonfuls in 24 hours. Children 6 to under 12 years of age - 1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls in 24 hours."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE ENDAL® CD is subject to the Federal Controlled Substance Act (Schedule V). May be habit forming. Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic depedence, physical dependence and tolerance may develop upon repeated administration of ENDAL® CD, and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs."],"drug_interactions":["Drug Interactions Patients receiving other narcotic analgesics, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with ENDAL® CD may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with codeine preparations may increase the effect of either the antidepressant or hydrocodone. The concurrent use of anticholinergics with codeine may produce paralytic ileus. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect. MAO inhibitors and beta adrenergic blockers increase the effect of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids."],"effective_time":"20110329","how_supplied":["HOW SUPPLIED: ENDAL® CD is supplied in 16 fl. oz. (473 mL) bottles as a cherry-flavored, sugar-free, alcohol-free, dye-free, clear syrup, NDC 23589-046-16. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature]. 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: TIBER LABORATORIES Suwanee, GA 30024 U.S. Patent #6,979,689 Manufactured by: Great Southern Laboratories Houston, TX 77099 Rev. 11/09"],"id":"5c2f2a37-8897-4314-ad1b-b0fc3babd6bf","indications_and_usage":["INDICATIONS ENDAL® CD is indicated for the symptomatic relief of cough, nasal and Eustachian tube congestion and discomfort associated with the common cold, sinusitis and acute upper respiratory tract infections."],"information_for_patients":["Information for Patients ENDAL® CD, like all narcotics and antihistamines, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly. Antihistamines may cause drowsiness and ambulatory patients who operate machinery and or motor vehicles should be cautioned accordingly. Cough Reflex Codeine, suppresses the cough reflex; as with all narcotics, caution should be exercised when ENDAL® CD is used postoperatively and in patients with pulmonary disease."],"labor_and_delivery":["Labor and Delivery As with all narcotics, administration of ENDAL® CD to the mother shortly before delivery may result in some degree of respiratory depression in the newborn especially if higher doses are used."],"nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ENDAL® CD, 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."],"openfda":{},"overdosage":["OVERDOSAGE Overdose effects of Codeine phosphate may include cold, clammy skin; confusion; convulsions; severe dizziness; drowsiness; nervousness or restlessness; weakness; low blood pressure; pinpoint pupils; slow heartbeat; slow or troubled breathing; and unconsciousness. Treatment: Recommended treatment of opioid analgesic overdose may consist of the following: induced vomiting or perform gastric lavage (if the opioid was taken orally). Administer naloxone (an opioid antagonist) as a single dose of between 400 micrograms and 2 mg, preferably by intravenous infusion. Administer intravenous fluids and/or vasopressors and use other supportive measures as needed. Continuously monitor patient (mandatory because the duration of action of the opioid may exceed that of the antagonist) and administer additional naloxone as needed. Alternatively, initial treatment may be followed by continuous intravenous infusion of naloxone. Gastric emptying may be useful in removing unabsorbed drug. Diphenhydramine Hydrochloride Mild overdose of diphenhydramine leads to sedation. Moderate to severe diphenhydramine overdose produces predictable anticholinergic effects: agitated delirium, mydriasis, dry mouth, decreased gastrointestinal motility, urinary retention, and erythema. Rarely, diphenhydramine overdose may cause rhabdomyolysis. Life-threatening overdose is characterized by hyperthermia (from a combination of musculoskeletal action in an agitated patient who is unable to lose heat because of an inability to sweat), seizures, and ventricular tachycardia. Mild to moderate overdoses can be treated supportively. Sedation for severe agitation can be accomplished by intravenous benzodiazepines or physostigmine. Ventricular arrhythmia is treated with intravenous sodium bicarbonate or hypertonic saline."],"package_label_principal_display_panel":["PRODUCT PACKAGING: The packaging below represents the labeling currently used: Principal Display Panel and Side Panel: NDC 23589-046-16 TIBER LABORATORIES Rx Only Endal® CD Syrup Cough Suppressant / Decongestant / Antihistamine Cherry Flavor Each 5 mL (teaspoonful) contains: Codeine Phosphate................. 7.5 mg (WARNING: MAY BE HABIT-FORMING) Phenylephrine HCl.................. 7.5 mg Diphenhydramine HCl.............. 10 mg CV Sugar Free / Alcohol Free / Dye-Free NET: 1 PINT (473 mL) DOSAGE AND ADMINISTRATION: Adults and children 12 years of age and over- 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 8 teaspoonfuls in 24 hours. Children 6 to under 12 years of age- 1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls in 24 hours. Refer to the attached package insert for complete dosing information. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature]. 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 bottle is not to be dispensed to consumer. Manufactured for: TIBER LABORATORIES Suwanee, GA 30024 U.S. Patent #6,979,689 Manufactured by: Great Southern Laboratories Houston, TX 77099 Rev. 11/09 Endal CD Packaging Endal CD Packaging Endal CD Packaging"],"pediatric_use":["Pediatric Use Safety and effectiveness in children have not been established."],"precautions":["PRECAUTIONS Special Risk Patients As with any narcotic analgesic agent, ENDAL® CD should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Use diphenhydramine hydrochloride with precaution in patients with narrow-angle glaucoma, stenosing peptic ulcer disease, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction, history or bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, or hypertension. Elderly are more susceptible to the side effects of diphenhydramine. Concomitant use of CNS depressants, including alcohol, may potentiate the sedative effects of diphenhydramine. Information for Patients ENDAL® CD, like all narcotics and antihistamines, may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly. Antihistamines may cause drowsiness and ambulatory patients who operate machinery and or motor vehicles should be cautioned accordingly. Cough Reflex Codeine, suppresses the cough reflex; as with all narcotics, caution should be exercised when ENDAL® CD is used postoperatively and in patients with pulmonary disease. Drug Interactions Patients receiving other narcotic analgesics, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with ENDAL® CD may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with codeine preparations may increase the effect of either the antidepressant or hydrocodone. The concurrent use of anticholinergics with codeine may produce paralytic ileus. Concomitant use of antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect. MAO inhibitors and beta adrenergic blockers increase the effect of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to determine mutagenic and carcinogenic potential have not been performed. Usage in Pregnancy Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with ENDAL® CD. It is also not known whether ENDAL® CD can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ENDAL® CD should be given to a pregnant woman only if clearly needed. Codeine has been shown to be teratogenic in hamsters when given in doses 700 times the human dose. There are no adequate and well-controlled studies in pregnant women. ENDAL® CD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1 mg/kg q6h, and paregoric 2 to 4 drops/kg 4qh, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosage decreased as tolerated. Labor and Delivery As with all narcotics, administration of ENDAL® CD to the mother shortly before delivery may result in some degree of respiratory depression in the newborn especially if higher doses are used."],"pregnancy":["Usage in Pregnancy Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with ENDAL® CD. It is also not known whether ENDAL® CD can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ENDAL® CD should be given to a pregnant woman only if clearly needed. Codeine has been shown to be teratogenic in hamsters when given in doses 700 times the human dose. There are no adequate and well-controlled studies in pregnant women. ENDAL® CD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7 to 1 mg/kg q6h, and paregoric 2 to 4 drops/kg 4qh, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosage decreased as tolerated."],"set_id":"9529fa4c-7855-4b0e-8d5c-ea10bba9a502","spl_product_data_elements":["Endal CD Codeine Phosphate, Phenylephrine Hydrochloride, and Diphenhydramine Hydrochloride Codeine Phosphate Codeine Phenylephrine Hydrochloride Phenylephrine Diphenhydramine Hydrochloride Diphenhydramine CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL WATER SODIUM CITRATE SACCHARIN SODIUM SORBITOL"],"version":"3","warnings":["WARNINGS Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes melitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Diphenhydramine-containing products should not be used in combination with other diphenhydramine formulations; in rare cases toxic psychosis has occurred in children who received combinations of two or more diphenhydramine formulations by any route of administration including topically applied preparations. Respiratory Depression At high doses or in sensitive patients, codeine may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Codeine also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Head injury and Increased Intracranial Pressure The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Infants and Children Diphenhydramine should not be administered to premature or full-term neonates. Infants may have greater susceptibility than adults to the toxic effects of diphenhydramine. Adults who administer diphenhydramine to children should be aware that children may be at an increased risk for central nervous system stimulation. Antihistamines may impair mental alertness in children."]}