Bronchitol (Page 5 of 5)

Principal Display Panel — 40 mg 4 Week Carton Label

Rx Only

NDC 10122-212-56

Caution: Federal Law Prohibits Dispensing Without A Prescription

Bronchitol ®

(mannitol) inhalation powder

40 mg per capsule

FOR ORAL INHALATION ONLY

Do Not Swallow Bronchitol Capsules

Complete entire package (56 Blister Packs) for 28 days treatment

Contents:

56 Blister Cards: 560 capsules (40 mg each)

4 Bronchitol devices: For use with enclosed capsules only

See package insert for complete dosage information

For more information, call 1-888-661-9260.

Principal Display Panel -- 40 mg 4 Week Carton Label
(click image for full-size original)

Principal Display Panel — 40 mg 7 Day Carton Label

Rx Only

NDC 10122-212-14

Bronchitol ®

(mannitol) inhalation powder

40 mg per capsule

FOR ORAL INHALATION ONLY

Do Not Swallow Bronchitol Capsules

Complete entire package (14 Blister Packs) for 7 days treatment

Contents:

  • 14 Blister Packs: 140 capsules (40 mg each)
  • 1 Bronchitol inhaler: For use with enclosed capsules only
  • Quick reference guide
  • Package Insert

See package insert for complete dosage information

For more information, call 1-888-661-9260.

Principal Display Panel -- 40 mg 7 Day Carton Label
(click image for full-size original)

Principal Display Panel — 40 mg Tolerance Test Carton Label

Rx Only

NDC 10122-212-02

Bronchitol ®

(mannitol) inhalation powder

Tolerance Test

40 mg per capsule

FOR ORAL INHALATION ONLY

Contents:

  • 1 Blister Pack: 10 capsules
  • 1 Bronchitol inhaler:
    For use with enclosed capsules only
  • Tolerance Test Instructions
  • Package Insert

The Bronchitol Tolerance Test MUST be completed to
identify bronchial hyperresponsiveness to mannitol
prior to prescribing Bronchitol. Read Tolerance Testinstructions for detailed procedure.

Do Not Swallow Bronchitol Capsules

Professional Sample — Not for Sale

Chiesi

Principal Display Panel -- 40 mg Tolerance Test Carton Label
(click image for full-size original)

Principal Display Panel — 40 mg Tolerance Test Carton Label

Rx Only

NDC 10122-212-04

Bronchitol ®

(mannitol) inhalation powder

Tolerance Test

40 mg per capsule

FOR ORAL INHALATION ONLY

Contents:

  • 1 Blister Pack: 10 capsules
  • 1 Bronchitol inhaler:
    For use with enclosed capsules only
  • Tolerance Test Instructions
  • Package Insert

The Bronchitol Tolerance Test MUST be completed to
identify bronchial hyperresponsiveness to mannitol
prior to prescribing Bronchitol. Read Tolerance Testinstructions for detailed procedure.

Do Not Swallow Bronchitol Capsules

Chiesi

Principal Display Panel -- 40 mg Tolerance Test Carton Label
(click image for full-size original)
BRONCHITOL mannitol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10122-212
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
mannitol (mannitol) mannitol 40 mg
Product Characteristics
Color white (Clear capsule with white powder) Score no score
Shape CAPSULE (CAPSULE) Size 15mm
Flavor Imprint Code PXS;40;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10122-212-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (10122-212-01)
1 NDC:10122-212-01 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (10122-212-02)
2 NDC:10122-212-04 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (10122-212-01)
2 NDC:10122-212-01 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (10122-212-04)
3 NDC:10122-212-14 14 BLISTER PACK in 1 CARTON contains a BLISTER PACK (10122-212-01)
3 NDC:10122-212-01 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (10122-212-14)
4 NDC:10122-212-56 4 CARTON in 1 BOX contains a CARTON (10122-212-14)
4 NDC:10122-212-14 14 BLISTER PACK in 1 CARTON This package is contained within the BOX (10122-212-56) and contains a BLISTER PACK (10122-212-01)
4 NDC:10122-212-01 10 CAPSULE in 1 BLISTER PACK This package is contained within a CARTON (10122-212-14) and a BOX (10122-212-56)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202049 02/01/2021
Labeler — Chiesi USA, Inc. (088084228)

Revised: 01/2022 Chiesi USA, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.