An overdose of Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid is a potentially lethal poly-drug overdose situation. In the event of an overdose seek medical attention or consult a Poison Control Center immediately. 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. Treatment Immediate treatment of an overdosage of Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid 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.

Adults and Children 12 years of age and older: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls (30 mL) in a 24 hour period. Children 6 to 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls (15 mL) in a 24 hour period. Not recommended for children under 6 years of age. *In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.

Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL Liquid is a grape-flavored liquid supplied in 16 oz. bottles, NDC 68032-489-16. 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. Storage: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from freezing. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Rx only Manufactured for:River’s Edge Pharmaceuticals, LLCSuwanee, GA 30024Rev. 02/10 489-10

NDC 68032-489-16 Dihydrocodeine 3 mg/BPM 4 mg/Phenyleph HCl 7.5 mg/5 mL LIQUID Antitussive • Antihistamine • Decongestant Each 5 mL (1 teaspoonful) for oral administration contains:Dihydrocodeine Bitartrate*............ 3 mg*(WARNING-May be habit forming)Brompheniramine Maleate ............ 4 mgPhenylephrine HCl ................... 7.5 mg Grape Flavor Rx Only 16 fl. oz. (473 mL) DOSAGE AND ADMINISTRATION*: Adul