J-MAX DHC (Page 2 of 2)

Adverse Reactions to J-MAX DHC

The most frequently observed adverse reactions with dihydrocodeine include light-headedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, and skin reactions. With the exception of constipation, tolerance develops to most of these effects. Other reactions that have been observed with dihydrocodeine or opioids include respiratory depression, orthostatic hypotension, cough suppression, confusion, diarrhea, miosis, abdominal pain, dry mouth, indigestion, anorexia, spasm of biliary tract, and urinary retention. Physical and psychological dependence are possibilities. Hypersensitivity reactions (include anaphylactoid reactions), hallucinations, vivid dreams, granulomatous interstitial nephritis, severe narcosis and acute renal failure have been reported rarely during dihydrocodeine administration. Other reactions observed with the ingredients in this product include lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children).

DRUG ABUSE AND DEPENDENCE

This combination product is subject to the provisions of the Controlled Substance Act and has been placed in Schedule III. Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeat administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid medications. Symptoms of dihydrocodeine withdrawal consist of irritability, restlessness, insomnia, diaphoresis, anxiety, and palpitations.

OVERDOSAGE

An overdose of this product is a potentially lethal poly-drug overdose situation, and consultation with a regional Poison Control Center is recommended. A listing of the Poison Control Centers can be found in a standard reference such as the Physician’s Desk Reference.

Signs and Symptoms:

Symptoms of an overdose include pinpoint pupils, respiratory depression, extreme somnolence progressing to stupor,loss of consciousness or coma, skeletal muscle flaccidity, cold and clammy skin and other symptoms common with narcotic overdosage. Convulsions, cardiovascular collapse, and death may occur. A single case of acute rhabdomyolysis associated with an overdose of dihydrocodeine has been reported.

Recommended Treatment:

Immediate treatment of an overdose of this product includes support of cardiovascular function and measures to reduce further drug absorption. Vomiting should be induced with syrup of ipecac. If the patient is alert and has adequate laryngeal reflexes, oral activated charcoal should follow. The first dose should be accompanied by an appropriate cathartic. Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be treated with fluids. Endotrachial intubation and respiration may be necessary. The pure opiod antagonist naloxaone or nalmexone is a specific antidote against respiratory depression that results from opioid overdose. Opioid antagonists should not be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose. They should be administered cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The prescribing information for the specific opioid antagonist should be consulted for details of their proper use.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

J-MAX DHC is supplied as a purple, alcohol free liquid with a grape flavor in 16 fl oz (473 mL) bottles, NDC 64661-070-16.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Rx Only

Manufactured by:

Great Southern Laboratories

Houston, TX 77099

Manufactured for:

JayMac Pharmaceuticals

Sunset, LA 70584

Rev. 04/08

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 473 mL label:

NDC 64661-070-16

J-MAX DHC

Liquid

Antitussive · Expectorant

CIII

Each teaspoonful (5 mL) for oral

administration contains:

Dihydrocodeine Bitartrate………………..7.5 mg

(WARNING: May be habit forming)

Guaifenesin………………………………..100 mg

ALCOHOL 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, SEEK 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

Mfd. by: Great Southern Laboratories, Houston, TX 77099

Mfd. for: JayMac Pharmaceuticals, Sunset, LA 70584 Rev. 04/08

J-MAX DHC Packaging
(click image for full-size original)
J-MAX DHC Packaging
(click image for full-size original)
J-MAX DHC Packaging
(click image for full-size original)
J-MAX DHC dihydrocodeine bitartrate, guaifenesin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64661-070
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
Guaifenesin (Guaifenesin) Guaifenesin 100 mg in 5 mL
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64661-070-16 473 mL in 1 BOTTLE None
2 NDC:64661-070-15 15 mL in 1 BOTTLE None
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

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