Tranexamic Acid: Package Insert and Label Information (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 30 Tablets Bottle Label

30
(click image for full-size original)

TRANEXAMIC ACID tranexamic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-772(NDC:69918-301)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRANEXAMIC ACID (TRANEXAMIC ACID) TRANEXAMIC ACID 650 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STARCH, CORN
POVIDONE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
STEARIC ACID
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape OVAL Size 17mm
Flavor Imprint Code FP650
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-772-13 30 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-772-11)
1 NDC:50268-772-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-772-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022430 09/16/2022
Labeler — AvPAK (832926666)

Revised: 09/2022 AvPAK

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