Renagel (Page 5 of 5)

17 PATIENT COUNSELING INFORMATION

17.1 Dosing Recommendations

The prescriber should inform patients to take Renagel with meals and adhere to their prescribed diets. Instructions should be given on concomitant medications that should be dosed apart from Renagel.

17.2 Adverse Reactions

Renagel may cause constipation that if left untreated, may lead to severe complications. Patients should be cautioned to report new onset or worsening of existing constipation promptly to their physician.

18 800MG LABEL

800mg Label
(click image for full-size original)

RENAGEL renagel tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53808-0777(NDC:58468-0021)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER HYDROCHLORIDE (SEVELAMER) SEVELAMER HYDROCHLORIDE 800 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STEARIC ACID
WATER
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
ISOPROPYL ALCOHOL
Product Characteristics
Color WHITE (WHITE) Score no score
Shape OVAL (OVAL) Size 19mm
Flavor Imprint Code RENAGEL;800
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53808-0777-1 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021179 07/01/2009
Labeler — DOH CENTRAL PHARMACY (829348114)
Establishment
Name Address ID/FEI Operations
DOH CENTRAL PHARMACY 829348114 repack (53808-0777)

Revised: 01/2017 DOH CENTRAL PHARMACY

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