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Respiratory Depression
At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.
Infants may have increased sensitivity to the respiratory depressant effects of opioids (see PRECAUTIONS, Pediatric Use). If use of hydrocodone bitartrate and acetaminophen oral solution in such patients is contemplated, it should be administered cautiously, in substantially reduced initial doses, by personnel experienced in administering opioids to infants, and with intensive monitoring.
Head Injury and Increased Intracranial Pressure
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
Acute Abdominal Conditions
The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Misuse, Abuse and Diversion of Opioids
Hydrocodone bitartrate and acetaminophen oral solution contains hydrocodone, an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.
Hydrocodone bitartrate and acetaminophen oral solution can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen oral solution in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).
There is currently no manufacturer warning information available for this drug.
Hydrocodone bitartrate and acetaminophen oral solution is indicated for the relief of moderate to moderately severe pain.
Hydrocodone bitartrate and acetaminophen is supplied in liquid form for oral administration.
Warning: May be habit forming (see PRECAUTIONS, Information for Patients, and DRUG ABUSE AND DEPENDENCE).
Hydrocodone bitartrate is an opioid analgesic and antitussive which occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Hydrocodone bitartrate and acetaminophen oral solution contains:
| Per 5 mL | Per 10 mL | Per 15 mL | |
| Hydrocodone Bitartrate | 2.5 mg | 5 mg | 7.5 mg |
| Acetaminophen | 167 mg | 334 mg | 500 mg |
| Alcohol | 7% | 7% | 7% |
In addition hydrocodone bitartrate and acetaminophen oral solution contains the following inactive ingredients: citric acid, glycerin, methylparaben, propylene glycol, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Yellow No. 10 as coloring and natural and artificial flavoring.