{"adverse_reactions":["ADVERSE REACTIONS Antihistamines: sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn weakness, polyuria and dysuria and, rarely, excitability in children. Sympathomimetic amines: Convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulty, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Antihistaminic and decongestant actions. Carbinoxamine maleate possesses H 1 antihistaminic activity and mild anticholinergic and sedative effects. Serum half-life for carbinoxamine is estimated to be 10-20 hours. Virtually no intact drug is excreted in the urine. Pseudoephedrine hydrochloride 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, pseudoephedrine has less pressor effect in normotensive adults. Serum half-life for pseudoephedrine is 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. About one half of the administered dose is excreted in the urine."],"contraindications":["CONTRAINDICATIONS Patients with hypersensitivity or idiosyncrasy to ingredients, patients taking monoamine oxidase (MAO) inhibitors, patients with narrow-angle glaucoma, urinary infection, peptic ulcer, severe hypertension or coronary artery disease, or patients undergoing an asthmatic attack."],"description":["DESCRIPTION Antihistamine/Decongestant for oral use Each teaspoonful (5 mL) contains: Carbinoxamine Maleate 2 mg Pseudoephedrine Hydrochloride 25 mg Chemical Structure INACTIVE INGREDIENTS Sodium Benzoate, Citric Acid, Glycerin, Sorbitol, Flavor and Purified Water. Carbinoxamine maleate (2-[p-chloro-a-[2-(dimethylamino)ethoxy]benzylpyridine maleate) is one of the ethanolamine class of H 1 antihistamines. Pseudoephedrine hydrochloride (Benzenemethanol, α-[1-(methylamino)ethyl]-,[S-( R *, R *)]-, hydrochloride) is the hydrochloride of pseudoephedrine, a naturally occurring dextrorotary stereoisomer of ephedrine. Chemical Structure"],"description_table":["
Carbinoxamine Maleate 2 mg
Pseudoephedrine Hydrochloride 25 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION AGE DOSAGE FREQUENCY in mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate. Adults and Children 6 years and over 2 teaspoons q.i.d. Children 18 months to 6 years 1 teaspoon q.i.d. Under 18 months of age 9-18 months 3/4 - 1 teaspoon 6-9 months 3/4 - teaspoon 3-6 months 1/2 - teaspoon 1-3 months 1/4 - teaspoon (titrate dosage individually)"],"dosage_and_administration_table":["
AGE DOSAGE FREQUENCYin mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.
Adults and Children 6 years and over 2 teaspoons q.i.d.
Children 18 months to 6 years 1 teaspoon q.i.d.
Under 18 months of age
9-18 months 3/4 - 1 teaspoon
6-9 months 3/4 - teaspoon
3-6 months 1/2 - teaspoon
1-3 months 1/4 - teaspoon
(titrate dosage individually)
"],"drug_interactions":["Drug interactions antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol, and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa and mecamylamine. Effects of sympathomimetics are increased with MAO inhibitors and beta-adrenergic blockers."],"effective_time":"20101029","how_supplied":["HOW SUPPLIED Coldec DS is a strawberry/pineapple fruit flavored syrup available in 16 fl. oz. (1 pint) bottles. NDC 51991-309-16 Dispense in USP tight container. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP controlled room temperature."],"id":"1e9f984a-685f-4c98-b4d4-683445950448","indications_and_usage":["INDICATIONS AND USAGE For symptomatic relief of seasonal and perennial allergic rhinitis and vasomotor rhinitis. Coldec DS Syrup is an immediate-release dosage form allowing titration of dose up to four times a day."],"information_for_patients":["Information for patients Avoid alcohol and other CNS depressants while taking these products. Patients sensitive to antihistamines may experience moderate to severe drowsiness. Patients sensitive to sympathomimetic amines may note mild CNS stimulation. When taking these products, exercise care in driving or operating appliances, machinery, etc."],"nursing_mothers":["Nursing Mothers Use with caution in nursing mothers."],"openfda":{},"overdosage":["OVERDOSAGE No information is available as to specific results of an overdose on these products. The signs, symptoms, and treatment described below are those of H 1 antihistamines and ephedrine overdose. Symptoms Should antihistamine effects predominate, central action constitutes the greatest danger. In a small child, symptoms include excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable. Should sympathomimetic symptoms predominate, central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea and abdominal cramps. Treatment a) Evacuate stomach as condition warrants. Activated charcoal may be useful. b) maintain a non-stimulating environment. c) monitor cardiovascular status. d) Do not give stimulants. e) Reduce fever with cool sponging. f) Support respiration. g) Use sedatives or anticonvulsants to control CNS excitation and convulsions. h) Physostigmine may reverse anticholinergic symptoms. i) ammonium chloride may acidify the urine to increase excretion of pseudoephedrine. j) further care is symptomatic and supportive."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 ml Bottle Label Breckenridge Pharmaceutical, Inc. NDC 51991-309-16 New Formula Coldec DS Antihistamine/Decongestant • Dye Free • Sugar Free • Alcohol Free Description: Each teaspoonful (5 mL) contains: Carbinoxamine Maleate 2 mg Pseudoephedrine HCl 25 mg INACTIVE INGREDIENTS: Sodium Benzoate, Citric Acid, Glycerin, Sorbitol, Flavor and Purified Water. Rx Only Net Contents: 16 fl. oz. (One Pint) 473 ml PRINCIPAL DISPLAY PANEL - 473 ml Bottle Label"],"precautions":["PRECAUTIONS Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes melitus and prostatic hypertrophy. Information for patients Avoid alcohol and other CNS depressants while taking these products. Patients sensitive to antihistamines may experience moderate to severe drowsiness. Patients sensitive to sympathomimetic amines may note mild CNS stimulation. When taking these products, exercise care in driving or operating appliances, machinery, etc. Drug interactions antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol, and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa and mecamylamine. Effects of sympathomimetics are increased with MAO inhibitors and beta-adrenergic blockers. Pregnancy Category C Animal Reproduction studies have not been conducted with these products. It is also not known whether these products can cause fetal harm when administered to a pregnant woman or effect reproduction capacity. Give to a pregnant woman only if clearly needed."],"pregnancy":["Use in Pregnancy Pregnancy category C Safety for use during pregnancy has not been established.","Pregnancy Category C Animal Reproduction studies have not been conducted with these products. It is also not known whether these products can cause fetal harm when administered to a pregnant woman or effect reproduction capacity. Give to a pregnant woman only if clearly needed."],"set_id":"d21406a4-0d17-4dfc-a5db-304e217ee319","spl_product_data_elements":["Coldec DS Carbinoxamine Maleate and Pseudoephedrine Hydrochloride Carbinoxamine Maleate Carbinoxamine Pseudoephedrine Hydrochloride Pseudoephedrine Sodium Benzoate Citric Acid Monohydrate Glycerin Sorbitol Water Clear"],"spl_unclassified_section":["Rx Only Manufactured for: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Manufactured by: Tri-Med Laboratories, Inc. Somerset NJ 08873 REV. 3/03"],"storage_and_handling":["Dispense in USP tight container. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP controlled room temperature."],"teratogenic_effects":["Pregnancy category C Safety for use during pregnancy has not been established."],"version":"1","warnings":["WARNINGS Use in Pregnancy Pregnancy category C Safety for use during pregnancy has not been established. Nursing Mothers Use with caution in nursing mothers. Special Risk Patients Use with caution in patients with hypertension or ischemic heart disease, and persons older than 60 years."]}