written for health professionals. Do not use BONJESTA for a condition for which it was not prescribed. Do not give BONJESTA to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in BONJESTA?
Active ingredient: doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6).
Inactive ingredients: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.
Distributed by: Duchesnay USA, Inc., Bryn Mawr, PA, 19010
For more information, go to www.duchesnayusa.com or call 1-855-722-7734.
This Patient Information has been approved by the U.S. Food and Drug Administration
Issued: 11/2016
Package/Label Display Panel
Bottle Label-Outside Front Cover with Imprint Area for Lot & Expiry
NDC 55494-120-60
Bonjesta®
(doxylamine succinate and pyridoxine hydrochloride)
Extended-release tablets 20mg/20mg
WARNING: Swallow tablets whole.
Do not crush, chew, or split the tablets.
60 extended-release tablets
DUCHESNAY
Rx only
Bottle Label-Outside Front Cover with Imprint Area for Lot & Expiry
Bottle Label – Inside Cover
Bottle Label – Inside Cover
INGREDIENTS AND APPEARANCE
BONJESTA
doxylamine succinate and pyridoxine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55494-120
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name
Strength
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALCOHOL (UNII: 3K9958V90M)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL ALCOHOL (UNII: ND2M
