Galantamine (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Galantamine Tablets USP are supplied as follows:

4 mg white color film coated, round, biconvex tablet, debossed “YB” on one side and “111” on the other side. Bottle of 60 (NDC 70436-004-06)

8 mg purple color film coated, round, biconvex tablet, debossed “YB” on one side and “112” on the other side. Bottle of 60 (NDC 70436-005-06)

12 mg peach color film coated, round, biconvex tablet, debossed “YB” on one side and “113” on the other side. Bottle of 60 (NDC 70436-006-06)

Storage and Handling

Galantamine Tablets USP should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Serious Skin Reactions

Advise patients and caregivers to discontinue galantamine tablets and seek immediate medical attention at the first appearance of skin rash [see Warnings and Precautions (5.1)] .

General Dosing Guidance

Instruct caregivers about the recommended dosage and administration of galantamine tablets. Galantamine tablets should be administered twice per day, preferably with the morning and evening meals. Dose escalation (dose increases) should follow a minimum of four weeks at prior dose. If therapy has been interrupted for more than three days, the patient should be restarted with the lowest dose and then re-titrated to an appropriate dosage [see Dosage and Administration (2)] .

Advise patients and caregivers to ensure adequate fluid intake during treatment [see Dosage and Administration (2)] .

Advise patients and caregivers that the most frequent adverse events associated with use of the drug can be minimized by following the recommended dosage and administration.

Manufactured by:
Yabao Pharmaceutical Co., Ltd. Beijing
Beijing, China 101111

Distributed by:
Slate Run Pharmaceuticals, LLC
Columbus, Ohio 43215

Revised Jan 2022

P17805

PRINCIPAL DISPLAY PANEL — 4 mg Tablet Label

60 TABLETS NDC 70436-004-06

Galantamine Tablets USP

4 mg

PRINCIPAL DISPLAY PANEL -- 4 mg Tablet Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 8 mg Tablet Label

60 TABLETS NDC 70436-005-06

Galantamine Tablets USP

8 mg

PRINCIPAL DISPLAY PANEL -- 8 mg Tablet Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 12 mg Tablet Label

60 TABLETS NDC 70436-006-06

Galantamine Tablets USP

12 mg

PRINCIPAL DISPLAY PANEL -- 12 mg Tablet Label
(click image for full-size original)

GALANTAMINE galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-004
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 4 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND (biconvex) Size 5mm
Flavor Imprint Code YB;111
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-004-06 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077604 08/02/2017
GALANTAMINE galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 8 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
CROSPOVIDONE
D&C RED NO. 27
FD&C BLUE NO. 1
Product Characteristics
Color purple Score no score
Shape ROUND (biconvex) Size 7mm
Flavor Imprint Code YB;112
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-005-06 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077604 08/02/2017
GALANTAMINE galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-006
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 12 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color pink (PEACH COLOR) Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code YB;113
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-006-06 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077604 08/02/2017
Labeler — Slate Run Pharmaceuticals, LLC (039452765)
Establishment
Name Address ID/FEI Operations
Yabao Pharmaceutical Co., Ltd. Beijing 421252976 manufacture (70436-004), manufacture (70436-005), manufacture (70436-006)

Revised: 01/2022 Slate Run Pharmaceuticals, LLC

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