Other adverse reactions observed with the ingredients in Coldcough™ PD 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 V. 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 repeated administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral opioid medications. Symptoms of dihydrocodeine withdrawal consist of irritability, restlessness, insomnia, diaphoresis, anxiety and palpitations.

OVERDOSAGE
An overdose of Coldcough™ PD 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 standard references such as the Physicians Desk Reference.

Signs and Symptoms
Symptoms of overdosage 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 overdosage of Coldcough™ PD includes support of cardiorespiratory function and measures to reduce 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. Endotracheal intubation and artificial respiration may be necessary. The pure opioid antagonist naloxone or nalmefene 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 Adolescents over 12 years
1 to 2 teaspoonfuls (5 mL to 10 mL). (Not to exceed 8 teaspoonfuls (40 mL) in 24 hours).

Children 6 to 12 years of age
1/2 to 1 teaspoonful (2.5 mL to 5 mL). (Not to exceed 4 teaspoonfuls (20 mL) in 24 hours).

These doses may be given every four to six hours as needed.

This product is not indicated for use in children under 6 years of age. (See PRECAUTIONS, Pediatric Use.)

HOW SUPPLIED
Coldcough™ PD is a sugar-free, alcohol