Consumer Product Safety Improvement Act

 

Pursuant to the Consumer Product Safety Improvement Act (CPSIA), manufacturers of imported or domestically manufactured (U.S.A.) prescription drug products that are subject to a consumer product safety rule, ban, standard or regulation enforced by the Consumer Product Safety Commission (CPSC), are required to provide General Certificates of Conformance (GCC). 

Takeda manufactures prescription drug products that are governed under the CPSC regulations.  The Takeda GCC certifies that the product (the child-resistant package) complies with the Poison Prevention Packaging Act (PPPA) requirements for special packaging under 16 CFR ยง 1700.

The GCCs are maintained to reflect additions of new products and existing product changes.  Please see CPSC regulations for further information.

See product specific GCC listings below.

 

Name Dosage Type Prescribing Information
ACTOS (pioglitazone)

30ct bottle, 15mg tablet
30ct bottle, 30mg tablet
30ct bottle, 45mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
ACTOplus met (pioglitazone and metformin HCI)

60ct bottle, 15mg/500mg tablet
60ct bottle, 15mg/850mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide

ACTOplus met XR (pioglitazone and metformin HCI) (extended release)

30ct bottle, 15mg/1000mg tablet
30ct bottle, 30mg/1000mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
COLCRYS (colchicine)

30ct bottle, 0.6mg tablet
100ct bottle, 0.6mg tablet

Tablet Click here for Prescribing Information including medication guide
DEXILANT (dexlansoprazole)

5ct bottle, 30mg capsule
5ct bottle, 60mg capsule
30ct bottle, 30 mg capsule
30ct bottle, 60mg capsule
90ct bottle, 60mg capsule

Capsule


Click here for Prescribing Information including medication guide

Duetact (pioglitazone and glimepiride)

30ct bottle, 30mg/2mg tablet
30ct bottle, 30mg/4mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
KAZANO (alogliptin and metformin HCI)

60ct bottle, 12.5mg/500mg tablet
60ct bottle, 12.5mg/1000mg tablet

Tablet

Click here for Prescribing Information including boxed warning, and medication guide
NESINA (alogliptin)

30ct bottle, 12.5mg tablet
30ct bottle, 25mg tablet
30ct bottle, 6.25mg tablet

Tablet Click here for Prescribing Information including medication guide
OSENI (alogliptin and pioglitazone)

30ct bottle, 12.5mg/15mg tablet
30ct bottle, 12.5mg/30mg tablet
30ct bottle, 12.5mg/45mg tablet
30ct bottle, 25mg/15mg tablet
30ct bottle, 25mg/30mg tablet
30ct bottle, 25mg/45mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
PREVACID (lansoprazole)

30ct bottle, 15mg capsule
100ct bottle, 30mg capsule

Capsule Click here for Prescribing Information including medication guide
ROZEREM (ramelteon)

30ct bottle, 8mg tablet
100ct bottle, 8mg tablet

Tablet Click here for Prescribing Information including medication guide
TRINTELLIX (vortioxetine)

7ct bottle, 5mg tablet
7ct bottle, 10mg tablet
30ct bottle, 5mg tablet
30ct bottle, 10mg tablet
30ct bottle, 20mg tablet

Tablet Click here for Prescribing Information including boxed warning and medication guide
ULORIC (febuxostat)

7ct bottle, 40mg tablet
7ct bottle, 80mg tablet
30ct bottle, 40mg tablet
30ct bottle, 80mg tablet

Tablet Click here for Prescribing Information

 

ACTOS, ACTOplus met, ACTOplus met XR, and Duetact are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

COLCRYS is a trademark of Takeda Pharmaceuticals U.S.A., Inc., registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

DEXILANT and DEXILANT (with design) are trademarks of Takeda Pharmaceuticals U.S.A., Inc., registered in the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

KAZANO is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

NESINA is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

OSENI is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

PREVACID is a trademark registered in the U.S. Patent and Trademark Office and SoluTab is a trademark of Takeda Pharmaceuticals U. S. A., Inc. and used under license by Takeda Pharmaceuticals America, Inc.

Rozerem is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

TRINTELLIX is a trademark of H. Lundbeck A/S and used under license by Takeda Pharmaceuticals America, Inc.

ULORIC is a trademark of Teijin Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.