Gabapentin: Package Insert and Label Information (Page 5 of 5)

Dosage in Elderly

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.

HOW SUPPLIED

GABAPENTIN CAPSULES are supplied as follows:

Gabapentin capsules, 100 mg, white opaque/white opaque, imprinted MUTUAL 680 on both the body and cap

Bottles of 30 NDC 53489-284-07
Bottles of 60 NDC 53489-284-06
Bottles of 100 NDC 53489-284-01
Bottles of 250 NDC 53489-284-03
Bottles of 500 NDC 53489-284-05
Bottles of 1000 NDC 53489-284-10

Gabapentin capsules, 300 mg, yellow opaque/yellow opaque, imprinted Mutual 681 on both the body and cap

Bottles of 30 NDC 53489-285-07
Bottles of 60 NDC 53489-285-06
Bottles of 100 NDC 53489-285-01
Bottles of 250 NDC 53489-285-03
Bottles of 500 NDC 53489-285-05
Bottles of 1000 NDC 53489-285-10

Gabapentin capsules, 400 mg, rich yellow opaque/rich yellow opaque, imprinted Mutual 682 on both the body and cap

Bottles of 30 NDC 53489-286-07
Bottles of 60 NDC 53489-286-06
Bottles of 100 NDC 53489-286-01
Bottles of 250 NDC 53489-286-03
Bottles of 500 NDC 53489-286-05
Bottles of 1000 NDC 53489-286-10

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

Dispense in a tight, light-resistant container with a child-resistant closure.

Maalox® is a registered trademark of Novartis Consumer Health, Inc.

Manufactured By:
MUTUAL PHARMACEUTICAL COMPANY, INC.Philadelphia, PA 19124 USA

Rev: May 2006S

GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-284
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Gabapentin (Gabapentin) Gabapentin 100 mg
Inactive Ingredients
Ingredient Name Strength
Corn starch
talc
gelatin
titanium dioxide
FD&C Blue #2
FD&C Red #40
FD&C Blue #1
D&C Yellow #10 Lake
Product Characteristics
Color WHITE (Opaque/white opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Mutual;680
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53489-284-07 30 CAPSULE (30 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:53489-284-06 60 CAPSULE (60 CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:53489-284-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
4 NDC:53489-284-03 250 CAPSULE (250 CAPSULE) in 1 BOTTLE, PLASTIC None
5 NDC:53489-284-05 500 CAPSULE (500 CAPSULE) in 1 BOTTLE, PLASTIC None
6 NDC:53489-284-10 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE, PLASTIC None
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-285
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Gabapentin (Gabapentin) Gabapentin 300 mg
Inactive Ingredients
Ingredient Name Strength
Corn starch
talc
gelatin
titanium dioxide
D&C Yellow #10
D&C Red #33
FD&C Blue #2
FD&C Red #40
FD&C Blue #1
D&C Yellow #10 Lake
Product Characteristics
Color YELLOW (Opaque/yellow opaque) Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code Mutual;681
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53489-285-07 30 CAPSULE (30 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:53489-285-06 60 CAPSULE (60 CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:53489-285-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
4 NDC:53489-285-03 250 CAPSULE (250 CAPSULE) in 1 BOTTLE, PLASTIC None
5 NDC:53489-285-05 500 CAPSULE (500 CAPSULE) in 1 BOTTLE, PLASTIC None
6 NDC:53489-285-10 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE, PLASTIC None
GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-286
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Gabapentin (Gabapentin) Gabapentin 400 mg
Inactive Ingredients
Ingredient Name Strength
Corn starch
talc
gelatin
titanium dioxide
yellow iron oxide
FD&C Blue #2
FD&C Red #40
FD&C Blue #1
D&C Yellow #10 Lake
Product Characteristics
Color YELLOW (Opaque/yellow opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Mutual;682
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53489-286-07 30 CAPSULE (30 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:53489-286-06 60 CAPSULE (60 CAPSULE) in 1 BOTTLE, PLASTIC None
3 NDC:53489-286-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
4 NDC:53489-286-03 250 CAPSULE (250 CAPSULE) in 1 BOTTLE, PLASTIC None
5 NDC:53489-286-05 500 CAPSULE (500 CAPSULE) in 1 BOTTLE, PLASTIC None
6 NDC:53489-286-10 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE, PLASTIC None
Labeler — MUTUAL PHARMACEUTICAL COMPANY, INC.

Revised: 01/2007 MUTUAL PHARMACEUTICAL COMPANY, INC.

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