Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.

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17 PATIENT COUNSELING INFORMATION

 

See FDA-approved patient labeling (Patient Information)

Somnolence

 

Inform women to avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using BONJESTA until cleared to do so.

 

Inform women of the importance of not taking BONJESTA with alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates and sleep aids because somnolence could worsen leading to falls or other accidents.

 

BONJESTA is a registered trademark of Duchesnay Inc.

 

U.S. Patent Nos. 9,089,489 & 7,560,122.

 

Manufactured by:

Duchesnay Inc.

950 boul. Michèle-Bohec

Blainville, Québec

Canada J7C 5E2

Distributed by:

Duchesnay USA, Inc.

Bryn Mawr, PA, 19010

Tel: 1-855-722-7734

Fax: 1-888-588-8508

www.duchesnayusa.com 

 

©2016, Duchesnay Inc. All rights reserved. 

Patient Package Insert

 

Patient Information 

 

BONJESTA (bonn jest ah)

 

(doxylamine succinate and pyridoxine hydrochloride),

 

extended-release tablets, for oral use

 

What is BONJESTA? 

 

• BONJESTA is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.

 

• It is not known if BONJESTA is safe and effective in women with severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum. Women with this condition may need to be hospitalized.

 

• It is not known if BONJESTA is safe and effective in children under 18 years of age.

 

Do not take BONJESTA if you: 

 

• are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in BONJESTA. See the end of this Patient Information leaflet for a complete list of ingredients in BONJESTA.

 

• take monoamine oxidase inhibitors (MAOIs). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including Marplan, Nardil, Emsam, Eldepryl, Zelapar, and Parnate.

 

Before taking BONJESTA, tell your healthcare provider about all of your medical conditions, including if you: 

 

• have asthma.

 

• have eye problems called increased intraocular pressure or narrow angle glaucoma.

 

• have a stomach problem called stenosing peptic ulcer or pyloroduodenal obstruction.

 

• have a bladder problem called urinary bladder-neck obstruction.

 

• are breastfeeding or plan to breastfeed.  BONJESTA can pass into your breast milk and may harm your baby. You should not breastfeed while using BONJESTA.