J-COF
JayMac Pharmaceuticals
Great Southern Laboratories
J-COF DHC
FULL PRESCRIBING INFORMATION: CONTENTS*
- CLINICAL PHARMACOLOGY
- J-COF INDICATIONS AND USAGE
- J-COF CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DRUG INTERACTIONS
- J-COF ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE AND ADMINSTRATION
- HOW SUPPLIED
- Product Packaging
FULL PRESCRIBING INFORMATION
CIIIJ-COF DHC
Liquid
Antitussive · Antihistamine
Decongestant
Rx Only
DESCRIPTION
(WARNING-May be habit forming)
Pseudoephedrine Hydrochloride is a decongestant having the chemical name, Benzenemethanol, α-[1-(methylamino) ethyl]-, [S-(R*,R*)-, hydrochloride. It has the following structural formula:
CLINICAL PHARMACOLOGY
1
J-COF INDICATIONS AND USAGE
J-COF CONTRAINDICATIONS
WARNINGS
General:Usage in Ambulatory Patients:
Respiratory Depression:
Hypertensive Effect:
Dependence:
PRECAUTIONS
General:DRUG INTERACTIONS
Other CNS Depressants:
Monoamine Oxidase Inhibitors:
Information for Patients:
- This product may inhibit mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
- Report any adverse experience occurring during therapy.
- Do not adjust the dose of this product without consulting the prescribing professional.
- Do not combine this product with alcohol or other central nervous system depressants.
- Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of opioids and other drug use during pregnancy on themselves and their unborn child. Patients should be advised that this product is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
Nonteratongenic Effects:
Labor and Delivery:
Nursing Mothers:
Pediatric Use:
Geriatric Use:
Hepatic Impairment:
Renal Impairment:
Pancreatic/biliary Tract Disease
J-COF ADVERSE REACTIONS
DRUG ABUSE AND DEPENDENCE
OVERDOSAGE
®Signs and Symptoms:
Recommended Treatment:
DOSAGE AND ADMINSTRATION
Adults and children over 12 years of age:Children 6 to 12 years of age
HOW SUPPLIED
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSION ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
STORAGE:
Rx Only
Product Packaging
NDC 64661-060-16
J-COF DHC
Liquid
Antitussive, Antihistamine,
Nasal Decongestant
CIII
Each teaspoonful (5 mL) for oral
administration contains:
(WARNING: May be habit forming)
SUGAR FREE · ALCOHOL FREE
DYE FREE
Rx Only
16 fl oz (473 mL)
USUAL DOSAGE: Adults and children over 12 years of age:
Children 6 to 12 years of age:
For full prescribing information see attached insert.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSE, SEE PROFESSIONAL ASSISTANCE
OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Rx Only
J-COFDihydrocodeine Bitartrate, Brompheniramine Maleate, Pseudoephedrine Hydrochloride LIQUID
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
