POLY HIST
Poly Pharmaceuticals, Inc.
Great Southern Laboratories
POLY HIST DHC
FULL PRESCRIBING INFORMATION: CONTENTS*
- POLY HIST DHC Liquid
- CLINICAL PHARMACOLOGY
- POLY HIST INDICATIONS AND USAGE
- POLY HIST CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DRUG INTERACTIONS
- Information for Patient/Caregivers:
- Pregnancy: Teratogenic Effects - Pregnancy Category C:
- Nonteratogenic Effects:
- Labor and Delivery:
- Pediatric Use:
- Geriatric Use:
- POLY HIST ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- POLY HIST DOSAGE AND ADMINISTRATION*
- HOW SUPPLIED
- Storage:
- PRODUCT PACKAGING:
FULL PRESCRIBING INFORMATION
POLY HIST DHC Liquid
CIIIRx Only
DESCRIPTION:
*WARNING
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CLINICAL PHARMACOLOGY
POLY HIST INDICATIONS AND USAGE
POLY HIST CONTRAINDICATIONS
WARNINGS
General:Usage in Ambulatory Patients:
Respiratory Depression:
Hypotensive Effect:
Dependence:
PRECAUTIONS
General:DRUG INTERACTIONS
General:Other Central Nervous System Depressants:
Monoamine Oxidase Inhibitors:
Information for Patient/Caregivers:
Pregnancy: Teratogenic Effects - Pregnancy Category C:
Nonteratogenic Effects:
Labor and Delivery:
Pediatric Use:
Geriatric Use:
Hepatic Impairment:
Renal Impairment:
Pancreatic/Biliary Tract Disease:
POLY HIST ADVERSE REACTIONS
DRUG ABUSE AND DEPENDENCE
OVERDOSAGE
Signs and Symptoms:
Recommended Treatment:
DOSAGE AND ADMINISTRATION*
Adults and Children 12 years of age and older:Children 6 to 12 years of age:
Not recommended for children under 6 years of age.
HOW SUPPLIED
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:
ooooooooRx only
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 HISTDihydrocodeine Bitartrate, Phenylephrine Hydrochloride, Pyrilamine Maleate LIQUID
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