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

PRINCIPAL DISPLAY PANEL — 3 mg Capsule Bottle Label

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

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

PRINCIPAL DISPLAY PANEL — 6 mg Capsule Bottle Label

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

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