RIVASTIGMINE TARTRATE (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Rivastigmine tartrate capsules, USP equivalent to 1.5 mg, 3 mg, 4.5 mg, or 6 mg of rivastigmine base are available as follows:
1.5 mg capsule – Yellow opaque / yellow opaque hard gelatin capsule of size “2” imprinted with “ap” logo on cap and “RIV1.5” on body in black ink containing white to off-white powder.

Bottles of 60 NDC 27241-090-06

Bottles of 500 NDC 27241-090-50

3 mg capsule – Orange opaque / orange opaque hard gelatin capsule of size “2” imprinted with “ap” logo on cap and “RIV3.0” on body in black ink containing white to off-white powder.
Bottles of 60 NDC 27241-091-06

Bottles of 500 NDC 27241-091-50

4.5 mg capsule – Red opaque / red opaque hard gelatin capsule of size “2” imprinted with “ap” logo on cap and “RIV4.5” on body in black ink containing white to off-white powder.

Bottles of 60 NDC 27241-092-06

Bottles of 500 NDC 27241-092-50
6 mg capsule – Red opaque / orange opaque hard gelatin capsule of size “2” imprinted with “ap” logo on cap and “RIV6.0” on body in black ink containing white to off-white powder.
Bottles of 60 NDC 27241-093-06

Bottles of 500 NDC 27241-093-50

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a tight container.

17 PATIENT COUNSELING INFORMATION

Gastrointestinal Adverse Reactions

Caregivers should be advised of the high incidence of nausea and vomiting associated with the use of the drug along with the possibility of anorexia and weight loss. Caregivers should be encouraged to monitor for these adverse events and inform the physician if they occur. It is critical to inform caregivers that if therapy has been interrupted for more than several days, the next dose should not be administered until they have discussed this with the physician [see Warnings and Precautions ( 5.1)].

Skin Reactions

Caregivers and patients should be advised that allergic skin reactions have been reported in association with rivastigmine tartrate regardless of formulation (capsules, oral solution or transdermal patch). In case of skin reaction while taking rivastigmine tartrate, patients should consult with their physician immediately [see Warnings and Precautions ( 5.2)].
Concomitant Use of Drugs with Cholinergic Action

Caregivers and patients should be advised that cholinomimetics, including rivastigmine, may exacerbate or induce extrapyramidal symptoms. Worsening in patients with Parkinson’s disease, including an increased incidence or intensity of tremor, has been observed [see Warnings and Precautions ( 5.3)].

Marketed by:
Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.

Made in India.
Revised: 02/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL — 1.5 mg Capsule Bottle Label

NDC 27241-090-06
60 Capsules
Rivastigmine Tartrate Capsules, USP
1.5 mg*
Rx Only ajanta

Rivastigmine_1.5_mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 3 mg Capsule Bottle Label

NDC 27241-091-06
60 Capsules
Rivastigmine Tartrate Capsules, USP
3 mg*
Rx Only
ajanta

Rivastigmine_3_mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4.5 mg Capsule Bottle Label

NDC 27241-092-06
60 Capsules
Rivastigmine Tartrate Capsules, USP
4.5 mg*
Rx Only ajanta

Rivastigmine_4.5_mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 6 mg Capsule Bottle Label

NDC 27241-093-06
60 Capsules
Rivastigmine Tartrate Capsules, USP
6 mg*
Rx Only ajanta

Rivastigmine_6_mg
(click image for full-size original)
RIVASTIGMINE TARTRATE rivastigmine tartrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-090
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIVASTIGMINE TARTRATE (RIVASTIGMINE) RIVASTIGMINE 1.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code ap;RIV1;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-090-06 60 CAPSULE in 1 BOTTLE None
2 NDC:27241-090-50 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207797 09/28/2017
RIVASTIGMINE TARTRATE rivastigmine tartrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-091
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIVASTIGMINE TARTRATE (RIVASTIGMINE) RIVASTIGMINE 3 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code ap;RIV3;0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-091-06 60 CAPSULE in 1 BOTTLE None
2 NDC:27241-091-50 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207797 09/28/2017
RIVASTIGMINE TARTRATE rivastigmine tartrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-092
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIVASTIGMINE TARTRATE (RIVASTIGMINE) RIVASTIGMINE 4.5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code ap;RIV4;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-092-06 60 CAPSULE in 1 BOTTLE None
2 NDC:27241-092-50 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207797 09/28/2017
RIVASTIGMINE TARTRATE rivastigmine tartrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-093
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIVASTIGMINE TARTRATE (RIVASTIGMINE) RIVASTIGMINE 6 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color RED, ORANGE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code ap;RIV6;0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-093-06 60 CAPSULE in 1 BOTTLE None
2 NDC:27241-093-50 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207797 09/28/2017
Labeler — Ajanta Pharma Limited (918594859)
Establishment
Name Address ID/FEI Operations
Ajanta Pharma Limited 918594859 MANUFACTURE (27241-090), MANUFACTURE (27241-091), MANUFACTURE (27241-092), MANUFACTURE (27241-093)

Revised: 02/2018 Ajanta Pharma Limited

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