Galantamine: Package Insert and Label Information (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Galantamine tablets USP are supplied as follows:
Galantamine Tablets USP, 4 mg are off-white, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘49’ on the other side.
Bottles of 60 NDC 57237-049-60

Galantamine Tablets USP, 8 mg are pink, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘50’ on the other side.
Bottles of 60 NDC 57237-050-60

Galantamine Tablets USP, 12 mg are orange-brown, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘51’ on the other side.
Bottles of 60 NDC 57237-051-60

Storage and Handling

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° 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.
Distributed by:
Rising Health, LLC
Saddle Brook, NJ 07663

Made in India
Code: TS/DRUGS/19/1993
Revised: 06/2020

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 4 mg (60 Tablets Bottle)

Rising® NDC 57237-049-60
Galantamine
Tablets, USP
4 mg
60 Tablets Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 4 mg (60 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 8 mg (60 Tablets Bottle)

Rising® NDC 57237-050-60
Galantamine
Tablets, USP
8 mg
60 Tablets Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 8 mg (60 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -12 mg (60 Tablets Bottle)

Rising® NDC 57237-051-60
Galantamine
Tablets, USP
12 mg
60 Tablets Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 12 mg (60 Tablets Bottle)
(click image for full-size original)

GALANTAMINE galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-049
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
PROPYLENE GLYCOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color WHITE (Off-white) Score no score
Shape ROUND (Biconvex) Size 5mm
Flavor Imprint Code F;49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-049-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090957 03/29/2011
GALANTAMINE galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-050
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
PROPYLENE GLYCOL
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code F;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-050-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090957 03/29/2011
GALANTAMINE galantamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-051
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
PROPYLENE GLYCOL
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FERRIC OXIDE RED
Product Characteristics
Color ORANGE (Orange-Brown) Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code F;51
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-051-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090957 03/29/2011
Labeler — Rising Health, LLC (080500961)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (57237-049), ANALYSIS (57237-050), ANALYSIS (57237-051), MANUFACTURE (57237-049), MANUFACTURE (57237-050), MANUFACTURE (57237-051)

Revised: 07/2020 Rising Health, LLC

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