FDA records indicate that there are no current recalls for this drug.
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Execlear C Recall
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Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.
History
There is currently no drug history available for this drug.
Other Information
ExeClear-C Syrup is a clear, colorless liquid with a fruit gum flavor for oral administration.
Each teaspoon (5 ml) of ExeClear-C Syrup contains:
Codeine* Phosphate USP …………………. 10 mg
(*Warning: May be habit Forming)
Guaifenesin USP ………………………………. 200 mg
Codeine phosphate has the chemical name 7, 8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Its molecular formula is C18H21NO3H3PO4 • ½H2O with a molecular weight of 406.37. It occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is freely soluble in water at 25°C; slightly soluble in ethanol. Following absorption codeine is metabolized by the liver and metabolic products are excreted in the urine. Its structure is as follows:
Guaifenesin has the chemical name 3-(2-methoxyphenoxy)-1,2-propanediol. Its molecular formula is C10H14O4, 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; 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. Its structure is as follows:
Sources
Execlear C Manufacturers
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Larken Laboratories, Inc.
Execlear C | Larken Laboratories, Inc.
Adults and children 12 years of age and older: 2 teaspoonfuls every 4 to 6 hours, not to exceed 12 teaspoonfuls. in 24 hours.
Children 6 years to under 12 years of age: 1 teaspoonful every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours.
Children 5 years to under 6 years of age (avg. 18kg (40 lbs)): 1⁄2 teaspoonful every 4 to 6 hours, not to exceed 2 teaspoonfuls in 24 hours.
Children 3 years to under 5 years of age (avg. 14kg (30 lbs) to 16kg (35 lbs)): 1⁄4 teaspoonful every 4 to 6 hours, not to exceed 1 teaspoonful in 24 hours.
Not recommended for children under the age of 3 unless as directed by a physician. Parents 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 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.
KEEP THIS 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.
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