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

25mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg container label

50mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg container label

100mg
(click image for full-size original)

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

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