Sodium Polystyrene Sulfonate (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

NDC 46287–006–01
473 mL

SPS^® Suspension

SODIUM POLYSTYRENE SULFONATE SUSPENSION, USP

For Oral or Rectal Use

Sodium Polystyrene Sulfonate USP 15 g/60 mL

Also contains: Sorbitol Solution USP (equivalent to
approximately 20 g of Sorbitol), Alcohol 0.3%, Purified
Water USP, Propylene Glycol USP, Magnesium Aluminum
Silicate NF, Sodium Saccharin USP, Methylparaben NF,
Propylparaben NF, & Flavor

Sodium content 1.5 g (65 mEq) in 60 mL

USUAL DOSE: See accompanying package insert for full
information.

Store at 20°-25°C (68°-77°F); excursions permitted
to 15°-30°C (59°-86°F). [See USP Controlled Room
Temperature].

Dispense in a tight container, as defined in the USP.

GTIN: 00346287006015

SHAKE WELL
Rx Only

cmp
PHARMA
Farmville, NC 27828

3064R1219

SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46287-006 Route of Administration ORAL, RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM POLYSTYRENE SULFONATE (POLYSTYRENE SULFONIC ACID) SODIUM POLYSTYRENE SULFONATE 15 g in 60 mL

Inactive Ingredients Ingredient Name Strength SORBITOL 21.5 mL in 60 mL ALCOHOL 0.18 mL in 60 mL WATER PROPYLENE GLYCOL MAGNESIUM ALUMINUM SILICATE SACCHARIN SODIUM METHYLPARABEN PROPYLPARABEN

Product Characteristics Color BROWN (Light) Score Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:46287-006-01 473 mL in 1 BOTTLE None 2 NDC:46287-006-04 120 mL in 1 BOTTLE None 3 NDC:46287-006-60 10 BOTTLE, UNIT-DOSE in 1 CARTON contains a BOTTLE, UNIT-DOSE 3 60 mL in 1 BOTTLE, UNIT-DOSE This package is contained within the CARTON (46287-006-60)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA087859 12/08/1982

Labeler — CMP Pharma, Inc. (005224175)

Establishment
Name	Address	ID/FEI	Operations
CMP Pharma, Inc.		005224175	MANUFACTURE (46287-006)

Revised: 08/2021 CMP Pharma, Inc.