Hydrocodone Polistirex and Chlorpheniramine Polistirex (Page 3 of 3)

DOSAGE AND ADMINISTRATION

It is important that hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension is measured with an accurate measuring device (see PRECAUTIONS, Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose.

Shake well before using.

Adults and Children 12 Years and Older

5 mL (1 teaspoonful) every 12 hours; do not exceed 10 mL (2 teaspoonfuls) in 24 hours.

Children 6 to 11 Years of Age

2.5 mL (½ teaspoonful) every 12 hours; do not exceed 5 mL (1 teaspoonful) in 24 hours.

This medicine is contraindicated in children under 6 years of age (see CONTRAINDICATIONS).

HOW SUPPLIED

Hydrocodone polistirex and chlorpheniramine polistirex ER oral suspension, equivalent to 10 mg of hydrocodone bitartrate and 8 mg of chlorpheniramine maleate per 5 mL is a yellow viscous suspension.

NDC 54868-6196-0 473 mL bottle

Storage:

Shake well. Dispense in a well-closed container.

Store at 20 to 25°C (68 to 77°F); excursions permitted from 15 to 30°C (59 to 86°F)

[see USP Controlled Room Temperature].

Distributed by:

Par Pharmaceutical Companies, Inc.

Spring, Valley, NY 10977

LB8072

Rev 00 OS235-01-72-01

I 04/10

Relabeling of “Additional Barcode Label” by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL – CONTAINER LABEL

image of package label
(click image for full-size original)
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
hydrocodone polistirex and chlorpheniramine polistirex suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6196(NDC:49884-235)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 10 mg in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 8 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
D&C YELLOW NO. 10
HIGH FRUCTOSE CORN SYRUP
METHYLPARABEN
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM ASCORBATE
SODIUM METABISULFITE
SODIUM POLYSTYRENE SULFONATE
SUCROSE
TRIACETIN
XANTHAN GUM
Product Characteristics
Color yellow Score
Shape Size
Flavor PEACH, PINEAPPLE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6196-0 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 473 mL in 1 BOTTLE This package is contained within the CARTON (54868-6196-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091632 11/03/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 10/2010 Physicians Total Care, Inc.

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