homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup


May be habit forming.

Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused.

Psychic dependence, physical dependence and tolerance may develop upon repeated administration of hydrocodone bitartrate and homatropine methylbromide and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs (see DRUG ABUSE AND DEPENDENCE ).

Respiratory Depression Hydrocodone bitartrate and homatropine methylbromide produces dose-related respiratory depression by directly acting on brain stem respiratory centers.

If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated.

Head Injury and Increased Intracranial Pressure The respiratory depression properties 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 pre-existing 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 hydrocodone bitartrate and homatropine methylbromide or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Pediatric Use In young pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner.

Benefit to risk ratio should be carefully considered especially in the pediatric population with respiratory embarrassment (e.g., croup).


Drug Interactions Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and homatropine methylbromide may exhibit an additive CNS depression.

When combined therapy is contemplated, the dose of one or both agents should be reduced.

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.


Signs and Symptoms Serious overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension.

In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

The ingestion of very large amounts of hydrocodone bitartrate and homatropine methylbromide may, in addition, result in acute homatropine intoxication.

Treatment Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation.

The narcotic antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to narcotics including hydrocodone.

Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation.

For further information, see full prescribing information for naloxone hydrochloride.

An antagonist should not be administered in the absence of clinically significant respiratory depression.

Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.

Gastric emptying may be useful in removing unabsorbed drug.


This product contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting narcotic antitussive.

Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.

Each teaspoonful (5 mL) for oral administration contains: Hydrocodone Bitartrate, USP 5 mg WARNING: May be habit forming.

Homatropine Methylbromide, USP 1.5 mg Hydrocodone Bitartrate and Homatropine Methylbromide Syrup also contains: Caramel color, cherry flavor, citric acid, FD&C Red #40, methylparaben, propylparaben, purified water, sorbitol solution and sucrose syrup.

Citric acid and/or sodium citrate may be added to adjust pH.

The hydrocodone component is a 4,5α- epoxy-3-methoxy-17-methylmorphinan- 6-one tartrate (1:1) hydrate (2:5), a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine, has a molecular weight of (494.50) and may be represented by the following structural formula: Homatropine methylbromide is 8- Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenylacetyl) oxy]-8,8-dimethyl-,bromide, endo-; a white crystal or fine white crystalline powder, with a molecular weight of (370.29).

Structural Formula for hydrocodone bitartrate Structural Formula for homatropine methylbromide


Hydrocodone Bitartrate and Homatropine Methylbromide Syrup is available as a clear red colored, cherry flavored syrup in: Bottles of 16 fl.


(one pint) ……

NDC 54868-5168-0 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container, as defined in the USP.

Oral prescription where permitted by state law.

Manufactured By: Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701 Rev.

043:00 3/09 MG #21271 Additional barcode label applied by: Physicians Total Care, Inc.

Tulsa, Oklahoma 74146


Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for the symptomatic relief of cough.


Pediatric Use Safety and effectiveness of hydrocodone bitartrate and homatropine methylbromide in pediatric patients under six have not been established.


Pregnancy Teratogenic Effects Pregnancy Category C: Animal reproduction studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide.

It is also not known whether hydrocodone bitartrate and homatropine methylbromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Hydrocodone bitartrate and homatropine methylbromide should be given to a pregnant woman only if clearly needed.

Nonteratogenic effects Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent.

The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever.

The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.


Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from hydrocodone bitartrate and homatropine methylbromide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.


Information for patients Hydrocodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

The patient using hydrocodone bitartrate and homatropine methylbromide should be cautioned accordingly.


Adults One (1) teaspoonful (5 mL) of the syrup every 4 to 6 hours as needed; do not exceed six (6) teaspoonfuls in 24 hours.

Children 6 to 12 Years of Age One-half (1/2) teaspoonful (2.5 mL) of the syrup every 4 to 6 hours as needed; do not exceed three (3) teaspoonfuls in 24 hours.