J-cof dhc

J-Cof DHC is part of the drug classes:

• Substituted alkylamines

• Natural opium alkaloids

• Sympathomimetics

This combination product is contraindicated  in patients with hypersensitivity to dihydrocodeine, codeine, or any of the active or inactive components listed above, or in any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitation equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.  Antihistamines are contraindicated in patients receiving antihypertensive or antidepressant drugs containing monoamine oxidase inhibitors (MAOI) since these agents may prolong and intensify the anticholinergic and CNS depressant effects of antihistamines (see Drug Interactions).

Antihistamines should not be used to treat or lower respiratory tract symptoms or be given to premature or newborn infants.

Sympathomemetic agents are contraindicated in patients with severe hypertension, severe coronary artery disease, patients with narrow angle glaucoma, bronchial asthma, urinary retention, peptic ulcer, and during an asthmatic attack.  This product is contraindicated in women who are pregnant.

General:  Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy.  The elderly (60 years and older) are more likely to exhibit adverse reactions.  Antihistamines may cause excitability, especially in children.  At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur.

Usage in Ambulatory Patients:  Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

Respiratory Depression:  Respiratory depression is the most dangerous acute reaction produced by opioid agonist preparations, although it is rarely severe with usual doses.  Opioids decrease the respiratory tidal volume, minute ventilation, and sensitivity to carbon dioxide.  Respiratory depression occurs most frequently in elderly or debilitated patients, usually after large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.  This combination product should be used with caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale and in patients with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or respiratory depression.

Hypertensive Effect:  Dihydrocodeine, like all opioid analgesics, may cause hypotention in patients whose ability to maintain blood pressure has been compromised by depleted blood volume or who received concurrent therapy with drugs such as phenothiazine or other agents which compromise vasomotor tone.  This product may produce orthostatic hypotension in ambulatory patients.  This combination product should be administered with caution to patients with circulatory shock since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Dependence:  Dihydrocodeine can produce drug dependence of the codeine type and has the potential of being abused.  This product should be prescribed and administered with the appropriate degree of caution (See Drug Abuse and Dependence section).

The packaging below represents the labeling currently used.

Principal display panel and side panel  for 473 mL label:

NDC 64661-060-16

J-COF DHC
Liquid

Antitussive, Antihistamine,
Nasal Decongestant

CIII

Each teaspoonful (5 mL) for oral
administration contains:
Dihydrocodeine Bitartrate...............................7.5 mg
    (WARNING:  May be habit forming)
Brompheniramine Maleate................................3 mg
Pseudoephedrine HCl.....................................15 mg

SUGAR FREE · ALCOHOL FREE
DYE FREE

Rx Only

16 fl oz (473 mL)

USUAL DOSAGE:  Adults and children over 12 years of age:  1 to 2 teaspoonfuls (5 mL to 10 mL),
every 4 to 6 hours as needed.  Children 6 to 12 years of age:  1/2 to 1 teaspoonful (2.5 mL to 5 mL),
every 4 to 6 hours as needed.

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.

Store at controlled room temperature, 15°-30°C (59°-86°F).

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.

Rx Only

Mfg. by:  Great Southern Laboratories, Houston, TX  77099
Mfg. for:  JayMac Pharmaceuticals, Sunset, LA  70584
Rev. 03/08

J-COF  DHC dihydrocodeine bitartrate, brompheniramine maleate, pseudoephedrine hydrochloride liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64661-060 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dihydrocodeine Bitartrate (Dihydrocodeine) Dihydrocodeine Bitartrate 7.5 mg  in 5 mL Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate 3 mg  in 5 mL Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 15 mg  in 5 mL

Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:64661-060-16 473 mL in 1 BOTTLE 2 NDC:64661-060-15 15 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/30/2008

Labeler - JayMac Pharmaceuticals (830767260)

Registrant - Great Southern Laboratories (056139553)

Establishment
Name	Address	ID/FEI	Operations
Great Southern Laboratories		056139553	manufacture

Revised: 02/2012   JayMac Pharmaceuticals