Poly Hist DHC
Name: Poly Hist DHC
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Poly Hist DHC Overview
Poly Hist DHC is a brand name medication included in the following groups of medications: Natural opium alkaloids, Adrenergic and dopaminergic agents, Sympathomimetics, Sympathomimetics excl. antiglaucoma preparations, Sympathomimetics used as decongestants, Sympathomimetics, combinations excl. corticosteroids, Sympathomimetics, plain, Antihistamines for topical use, Substituted ethylene diamines. For more information about Poly Hist DHC see its generics Dihydrocodeine, Mepyramine, Phenylephrine
Manufacturer
Poly Pharmaceuticals, Inc.
Drug Interactions
General: Sympathomimetics may reduce the antihypertensive effects of methyldopa,
mecamylamine, reserpine and veratrum alkaloids.
Other Central Nervous System Depressants: Patients receiving other opioid analgesics,
sedatives or hypnotics, muscle relaxants, general anesthetics, centrally acting anti-emetics,
phenothiazines or other tranquilizers, or alcohol concomitantly with this combination product
may exhibit additive depressant effects on the central nervous system. When such combined
therapy is contemplated, the dose of one or both agents should be reduced. Concomitant use
of dihydrocodeine and antihistamines with alcohol and other CNS depressants may have an
additive effect.
Monoamine Oxidase Inhibitors: Dihydrocodeine, like all opioids, interact with monoamine
oxidase inhibitors causing central nervous system excitation and hypertension. MAO inhibitors
and beta-adrenergic blockers increase the effects of sympathomimetics. They may also prolong
and intensify the anticholinergic effects of antihistamines.
mecamylamine, reserpine and veratrum alkaloids.
Other Central Nervous System Depressants: Patients receiving other opioid analgesics,
sedatives or hypnotics, muscle relaxants, general anesthetics, centrally acting anti-emetics,
phenothiazines or other tranquilizers, or alcohol concomitantly with this combination product
may exhibit additive depressant effects on the central nervous system. When such combined
therapy is contemplated, the dose of one or both agents should be reduced. Concomitant use
of dihydrocodeine and antihistamines with alcohol and other CNS depressants may have an
additive effect.
Monoamine Oxidase Inhibitors: Dihydrocodeine, like all opioids, interact with monoamine
oxidase inhibitors causing central nervous system excitation and hypertension. MAO inhibitors
and beta-adrenergic blockers increase the effects of sympathomimetics. They may also prolong
and intensify the anticholinergic effects of antihistamines.
Information for Patient/Caregivers
Patients receiving Poly Hist DHC Liquid should be given the following information:
1. Patients should be advised that Poly Hist DHC Liquid may impair the mental or
physical abilities required for the performance of potentially hazardous tasks such
as driving a car or operating machinery.
2. Patients should be advised to report adverse experiences occurring during therapy.
3. Patients should be advised not to adjust the dose of Poly Hist DHC Liquid without
consulting the prescribing professional.
4. Patients should not combine Poly Hist DHC Liquid with alcohol or other central
nervous system stimulants.
5. Women of childbearing potential who become, or are planning to become pregnant
should be advised to consult their physician regarding the effects of opioids and other
drug use during pregnancy on themselves and their unborn child.
Patients should be advised that Poly Hist DHC Liquid is a potential drug of abuse. They
should protect if from theft, and it should never be given to anyone other than the individual
for whom it was prescribed.
1. Patients should be advised that Poly Hist DHC Liquid may impair the mental or
physical abilities required for the performance of potentially hazardous tasks such
as driving a car or operating machinery.
2. Patients should be advised to report adverse experiences occurring during therapy.
3. Patients should be advised not to adjust the dose of Poly Hist DHC Liquid without
consulting the prescribing professional.
4. Patients should not combine Poly Hist DHC Liquid with alcohol or other central
nervous system stimulants.
5. Women of childbearing potential who become, or are planning to become pregnant
should be advised to consult their physician regarding the effects of opioids and other
drug use during pregnancy on themselves and their unborn child.
Patients should be advised that Poly Hist DHC Liquid is a potential drug of abuse. They
should protect if from theft, and it should never be given to anyone other than the individual
for whom it was prescribed.
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. There is no consensus on the best method of managing
withdrawal. Chlorpromazine 0.7-1.0 mg/kg q6h, phenobarbital 2 mg/kg q6h, and paregoric
24 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of
therapy is 4 to 28 days, with the dosages decreased as tolerated.
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. There is no consensus on the best method of managing
withdrawal. Chlorpromazine 0.7-1.0 mg/kg q6h, phenobarbital 2 mg/kg q6h, and paregoric
24 drops/kg q4h, have been used to treat withdrawal symptoms in infants. The duration of
therapy is 4 to 28 days, with the dosages decreased as tolerated.
Overdosage
An overdose of Poly Hist DHC Liquid 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 Physician's 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 Poly Hist DHC
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.
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 Physician's 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 Poly Hist DHC
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.
How is Poly Hist DHC Supplied
Poly Hist DHC is supplied as an alcohol free, gluten free, sugar free, fruit gum flavor,
clear colored liquid supplied in 16 oz. bottles (NDC 50991-521-16) and 15 mL professional
sample (NDC 50991-521-15).
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.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
clear colored liquid supplied in 16 oz. bottles (NDC 50991-521-16) and 15 mL professional
sample (NDC 50991-521-15).
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.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Product packaging
The packaging below represents the labeling currently used:
Principal Display Panel and Side Panel for 473mL Label:
NDC 50991-521-16
Poly Hist DHC
Antitussive / Decongestant / Antihistamine
Each 5 mL (1 teaspoonful) contains:
Dihydrocodeine Bitartrate*....... 7.5 mg
*(WARNING: May be habit forming)
Phenylephrine HCl.................... 5 mg
Pyrilamine Maleate................. 7.5 mg
Fruit Gum Flavor
Alcohol Free / Gluten Free
Sugar Free / Dye Free
CIII
Rx Only
Distributed by:
Poly Pharmaceuticals
Mobile, AL 36619
16 fl oz. (473 mL)
Side Panel:
DOSAGE AND ADMINISTRATION*: Adults and Children 12 years of age and older:
1 teaspoonful every 4 to 6 hours. Not to exceed 6 teaspoonfuls in a 24 hour period.
Children 6 to 12 years of age: 1/2 teaspoonful every 4 to 6 hours. Not to exceed 3
teaspoonfuls 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.
Refer to the attached package insert for full prescribing information.
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.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
This bottle is not to be dispensed to consumer.
Storage: Store at 20o-25oC (68o-77oF); excursions permitted to 15o-30oC (59o-86oF).
[See USP Controlled Room Temperature.] Protect from freezing.
Dispense in a tight, light-resistant container with a child-resistant cap.
Rx Only
Manufactured by: Great Southern Laboratories, Houston, TX 77099
Distributed for: Poly Pharmaceuticals, Mobile, AL 36619
Iss. 09/09
| POLY HIST DHC dihydrocodeine bitartrate, phenylephrine hydrochloride, pyrilamine maleate liquid | ||||||||||||||||||
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| Labeler - Poly Pharmaceuticals, Inc. (198449894) |
| Registrant - Great Southern Laboratories (056139553) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Great Southern Laboratories | 056139553 | manufacture | |