Pseudodine C Recall
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Questions & Answers
Side Effects & Adverse Reactions
Pseudodine™ C Cough Syrup should be used with considerable caution in patients with increased intraocular pressure (narrow angle glaucoma), stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder neck obstruction, hypertension, diabetes mellitus, ischemic heart disease, and hyperthyroidism.
In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure.
Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of patients with head injuries.
Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Pseudodine™ C Cough Syrup is indicated for temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
There is currently no drug history available for this drug.
Each 5 mL (teaspoonful) of Pseudodine™ C Cough Syrup for oral administration contains:
|Triprolidine Hydrochloride, USP .............||1.25 mg|
|Pseudoephedrine Hydrochloride, USP.....||30 mg|
|Codeine Phosphate, USP ........................||10 mg|
In addition, the following inactive ingredients are present: Artificial Fruit Flavor; Artificial Raspberry Flavor; Liquid Sugar; Menthol, USP; Methylparaben, NF; Propylene Glycol, USP; Purified Water, USP; Sodium Benzoate, NF; Sodium Citrate, USP and Sorbitol Solution, USP. It may also contain Citric Acid, USP.
Pseudodine™ C Cough Syrup has antitussive, antihistaminic and nasal decongestant effects. The components of this product have the following chemical names and structural formulas:
Codeine Phosphate, USP:
7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate.
C18H21NO3•H3PO4•½ H2O M.W. 406.37
Triprolidine Hydrochloride, USP:
(E)-2-[3-(1-Pyrrolidinyl)-1-p-tolylpropenyl]pyridine monohydrochloride monohydrate.
C19H22N2•HCl•H2O M.W. 332.87
Pseudoephedrine Hydrochloride, USP:
Benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)]-, hydrochloride.
C10H15NO•HCl M.W. 201.69