Acarbose (Page 4 of 4)

Maximum Dosage:

The maximum recommended dose for patient’s ≤ 60 kg is 50 mg t.i.d. The maximum recommended dose for patients > 60 kg is 100 mg t.i.d.

Patients Receiving Sulfonylureas or Insulin:

Sulfonylurea agents or insulin may cause hypoglycemia. Acarbose tablets given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose and may increase the potential for hypoglycemia. If hypoglycemia occurs, appropriate adjustments in the dosage of these agents should be made.

HOW SUPPLIED

Acarbose tablets 25 mg are white to yellowish, round biconvex tablets marked ” 318 ” on one face and ” cor ” on the other face.

They are supplied as follows:

Bottles of 90 NDC 42291-130-90
Bottles of 1000 NDC 42291-130-10

Acarbose tablets 50 mg are white to yellowish, round biconvex tablets marked ” 319 ” on one face and ” cor ” on the other face.

They are supplied as follows:

Bottles of 90 NDC 42291-131-90
Bottles of 1000 NDC 42291-131-10

Acarbose tablets 100 mg are white to yellowish, round biconvex tablets marked ” 320 ” on one face and ” cor ” on the other face.

They are supplied as follows:

Bottles of 90 NDC 42291-132-90
Bottles of 1000 NDC 42291-132-10

Store at 20ºC to 25ºC (68º to 77ºF).” [See USP Controlled Room Temperature].

Protect from moisture. Keep container tightly closed.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 06/13 AV 11/13 (P)

PRINCIPAL DISPLAY PANEL — 25 mg container label

PRINCIPAL DISPLAY PANEL — 50 mg container label

PRINCIPAL DISPLAY PANEL — 100 mg container label

ACARBOSE acarbose tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-130(NDC:69543-120) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACARBOSE (ACARBOSE) ACARBOSE 25 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE SILICON DIOXIDE

Product Characteristics Color white (White to yellowish) Score no score Shape ROUND Size 6mm Flavor Imprint Code cor;318 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-130-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091343 12/24/2013

ACARBOSE acarbose tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-131(NDC:69543-121) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACARBOSE (ACARBOSE) ACARBOSE 50 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE SILICON DIOXIDE

Product Characteristics Color white (White to yellowish) Score no score Shape ROUND Size 7mm Flavor Imprint Code cor;319 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-131-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091343 12/24/2013

ACARBOSE acarbose tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-132(NDC:69543-122) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACARBOSE (ACARBOSE) ACARBOSE 100 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE SILICON DIOXIDE

Product Characteristics Color white (white to yellowish) Score no score Shape ROUND Size 9mm Flavor Imprint Code cor;320 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42291-132-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091343 12/24/2013

Labeler — AvKARE (796560394)

Revised: 01/2022 AvKARE